Report Summaries
740 reports summarized with cited key findings.
- SFL — Aumseqa EMA EPAR public assessment report (EMEA/H/C/006069, 2026)SFL · 2026
- Eli Lilly and Company — Retevmo FDA Review (NDA/BLA 213246, 2026)Eli Lilly and Company · 2026
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026)Merck & Co., Inc. · 2026
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026)Merck & Co., Inc. · 2026
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026)Merck & Co., Inc. · 2026
- Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026)Novartis AG · 2026
- Amgen Inc. — Imdylltra EMA EPAR public assessment report (EMEA/H/C/006451, 2026)Amgen Inc. · 2026
- Bristol-Myers Squibb Company — Sprycel FDA Review (NDA/BLA 021986, 2026)Bristol-Myers Squibb Company · 2026
- Amgen Inc. — Imdelltra FDA Review (NDA/BLA 761344, 2026)Amgen Inc. · 2026
- Merck & Co., Inc. — Welireg FDA Review (NDA/BLA 215383, 2026)Merck & Co., Inc. · 2026
- Eli Lilly and Company — Retevmo FDA Review (NDA/BLA 213246, 2026)Eli Lilly and Company · 2026
- Eli Lilly and Company — Inluriyo EMA EPAR public assessment report (EMEA/H/C/006184, 2026)Eli Lilly and Company · 2026
- Ipsen S.A. — Ojemda EMA EPAR public assessment report (EMEA/H/C/006140, 2026)Ipsen S.A. · 2026
- Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H/C/006673, 2026)Mar S A · 2026
- SEATTLE GENETICS — Adcetris FDA Review (NDA/BLA 125388, 2026)Pfizer Inc. · 2026
- Ferring A S — Adstiladrin EMA EPAR public assessment report (EMEA/H/C/005856, 2026)Ferring A S · 2026
- GLAXOSMITHKLINE — Jemperli FDA Review (NDA/BLA 761174, 2026)GSK plc · 2026
- Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA/H/C/005697, 2025)Atnahs B V · 2025
- Autolus — Aucatzyl EMA EPAR public assessment report (EMEA/H/C/005907, 2025)Autolus · 2025
- AstraZeneca PLC — Lynparza FDA Review (NDA/BLA 208558, 2025)AstraZeneca PLC · 2025
- Amgen Inc. — Lumakras FDA Review (NDA/BLA 214665, 2025)Amgen Inc. · 2025
- Merck & Co., Inc. — Keytruda FDA Review (BLA761467, ORIG 1, 2025)Merck & Co., Inc. · 2025
- Merck & Co., Inc. — Welireg EMA EPAR public assessment report (EMEA/H/C/005636, 2025)Merck & Co., Inc. · 2025
- Johnson & Johnson — Lazcluze EMA EPAR public assessment report (EMEA/H/C/006074, 2025)Johnson & Johnson · 2025
- Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public assessment report (EMEA/H/C/006370, 2025)Regeneron Pharmaceuticals, Inc. · 2025
- Bristol-Myers Squibb Company — Augtyro EMA EPAR public assessment report (EMEA/H/C/006005, 2025)Bristol-Myers Squibb Company · 2025
- Deciphera B V — Romvimza EMA EPAR public assessment report (EMEA/H/C/006363, 2025)Deciphera B V · 2025
- Servier — Voranigo EMA EPAR public assessment report (EMEA/H/C/006284, 2025)Servier · 2025
- ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2025)Pfizer Inc. · 2025
- Accord S L U — Hetronifly EMA EPAR variation assessment report (EMEA/H/C/006170, 2025)Accord S L U · 2025
- Accord S L U — Hetronifly EMA EPAR public assessment report (EMEA/H/C/006170, 2025)Accord S L U · 2025
- Genmab A S — Tivdak EMA EPAR public assessment report (EMEA/H/C/005363, 2025)Genmab A S · 2025
- Merck B V — Ogsiveo EMA EPAR public assessment report (EMEA/H/C/006071, 2025)Merck B V · 2025
- Jazz — Ziihera EMA EPAR public assessment report (EMEA/H/C/006380, 2025)Jazz · 2025
- Daiichi Sankyo Company, Limited — Datroway EMA EPAR public assessment report (EMEA/H/C/006547, 2025)Daiichi Sankyo Company, Limited · 2025
- DAIICHI SANKYO — Enhertu FDA Review (NDA/BLA 761139, 2025)Daiichi Sankyo Company, Limited · 2025
- EMD SERONO INC — Tepmetko FDA Review (NDA/BLA 214096, 2025)Merck KGaA · 2025
- TAIHO ONCOLOGY — Lonsurf FDA Review (NDA/BLA 207981, 2025)Otsuka Holdings Co., Ltd. · 2025
- GLAXOSMITHKLINE — Zejula FDA Review (NDA/BLA 214876, 2025)GSK plc · 2025
- Novartis AG — Spexotras EMA EPAR public assessment report (EMEA/H/C/005886, 2024)Novartis AG · 2024
- Bristol-Myers Squibb Company — Krazati FDA Review (NDA/BLA 216340, 2024)Bristol-Myers Squibb Company · 2024
- Cstone — Cejemly EMA EPAR variation assessment report (EMEA/H/C/006088, 2024)Cstone · 2024
- BeOne Medicines Ltd. — Brukinsa FDA Review (NDA/BLA 213217, 2024)BeOne Medicines Ltd. · 2024
- AbbVie Inc. — Elahere EMA EPAR public assessment report (EMEA/H/C/005036, 2024)AbbVie Inc. · 2024
- Prestige Biopharma — Tuznue EMA EPAR public assessment report (EMEA/H/C/006252, 2024)Prestige Biopharma · 2024
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2024)Merck & Co., Inc. · 2024
- HOFFMANN-LA ROCHE — Alecensa FDA Review (NDA/BLA 208434, 2024)Roche Holding AG · 2024
- Topalliance Biosciences — Loqtorzi EMA EPAR public assessment report (EMEA/H/C/006120, 2024)Topalliance Biosciences · 2024
- Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BLA 761097, 2024)Regeneron Pharmaceuticals, Inc. · 2024
- Bristol-Myers Squibb Company — Krazati EMA EPAR public assessment report (EMEA/H/C/006013, 2024)Bristol-Myers Squibb Company · 2024
- AstraZeneca PLC — Truqap EMA EPAR public assessment report (EMEA/H/C/006017, 2024)AstraZeneca PLC · 2024
- SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2024)Sanofi · 2024
- BeOne Medicines Ltd. — Brukinsa FDA Review (NDA/BLA 213217, 2024)BeOne Medicines Ltd. · 2024
- Incyte Corporation — Zynyz EMA EPAR variation assessment report (EMEA/H/C/006194, 2024)Incyte Corporation · 2024
- Cstone — Cejemly EMA EPAR public assessment report (EMEA/H/C/006088, 2024)Cstone · 2024
- Bristol-Myers Squibb Company — Opdivo FDA Review (BLA761381, ORIG 1, 2024)Bristol-Myers Squibb Company · 2024
- Astellas Pharma Inc. — Vyloy EMA EPAR public assessment report (EMEA/H/C/005868, 2024)Astellas Pharma Inc. · 2024
- Unknown MAH — Balversa EMA EPAR public assessment report (EMEA/H/C/006050, 2024)Johnson & Johnson · 2024
- Incyte Corporation — Zynyz EMA EPAR public assessment report (EMEA/H/C/006194, 2024)Incyte Corporation · 2024
- Bristol-Myers Squibb Company — Augtyro FDA Review (NDA/BLA 218213, 2024)Bristol-Myers Squibb Company · 2024
- Novartis AG — Kisqali FDA Summary Review (NDA/BLA 209092, 2024)Novartis AG · 2024
- Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR public assessment report (EMEA/H/C/005979, 2024)Takeda Pharmaceutical Company Limited · 2024
- AstraZeneca PLC — Imjudo EMA EPAR public assessment report (EMEA/H/C/006016, 2023)AstraZeneca PLC · 2023
- Novartis AG — Finlee EMA EPAR public assessment report (EMEA/H/C/005885, 2023)Novartis AG · 2023
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2023)Merck & Co., Inc. · 2023
- BeOne Medicines Ltd. — Tevimbra EMA EPAR variation assessment report (EMEA/H/C/005919, 2023)BeOne Medicines Ltd. · 2023
- Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation assessment report (EMEA/H/C/005823, 2023)Otsuka Holdings Co., Ltd. · 2023
- Unknown MAH — Talvey EMA EPAR public assessment report (EMEA/H/C/005864, 2023)Johnson & Johnson · 2023
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2023)Bristol-Myers Squibb Company · 2023
- Servier — Tibsovo EMA EPAR public assessment report (EMEA/H/C/005936, 2023)Servier · 2023
- BeOne Medicines Ltd. — Tevimbra EMA EPAR variation assessment report (EMEA/H/C/005919, 2023)BeOne Medicines Ltd. · 2023
- Unknown MAH — Akeega EMA EPAR public assessment report (EMEA/H/C/005932, 2023)Johnson & Johnson · 2023
- Eli Lilly and Company — Jaypirca EMA EPAR variation assessment report (EMEA/H/C/005863, 2023)Eli Lilly and Company · 2023
- Unknown MAH — Akeega EMA EPAR variation assessment report (EMEA/H/C/005932, 2023)Johnson & Johnson · 2023
- EISAI INC — Lenvima FDA Review (NDA/BLA 206947, 2023)Eisai Co., Ltd. · 2023
- AbbVie Inc. — Tepkinly EMA EPAR variation assessment report (EMEA/H/C/005985, 2023)AbbVie Inc. · 2023
- GENENTECH — Avastin FDA Review (NDA/BLA 125085, 2023)Roche Holding AG · 2023
- Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023)Pfizer Inc. · 2023
- Stemline B V — Orserdu EMA EPAR public assessment report (EMEA/H/C/005898, 2023)Stemline B V · 2023
- BeOne Medicines Ltd. — Tevimbra EMA EPAR variation assessment report (EMEA/H/C/005919, 2023)BeOne Medicines Ltd. · 2023
- Roche Holding AG — Columvi EMA EPAR public assessment report (EMEA/H/C/005751, 2023)Roche Holding AG · 2023
- BeOne Medicines Ltd. — Tevimbra EMA EPAR public assessment report (EMEA/H/C/005919, 2023)BeOne Medicines Ltd. · 2023
- Otsuka Holdings Co., Ltd. — Lytgobi EMA EPAR public assessment report (EMEA/H/C/005627, 2023)Otsuka Holdings Co., Ltd. · 2023
- Eli Lilly and Company — Jaypirca EMA EPAR public assessment report (EMEA/H/C/005863, 2023)Eli Lilly and Company · 2023
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023)Merck & Co., Inc. · 2023
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023)Merck & Co., Inc. · 2023
- AstraZeneca PLC — Imjudo EMA EPAR variation assessment report (EMEA/H/C/006016, 2023)AstraZeneca PLC · 2023
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023)Merck & Co., Inc. · 2023
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023)Merck & Co., Inc. · 2023
- CHEPLAPHARM — Xeloda FDA Review (NDA/BLA 020896, 2023)Cheplapharm · 2023
- AstraZeneca PLC — Imjudo EMA EPAR variation assessment report (EMEA/H/C/006016, 2023)AstraZeneca PLC · 2023
- Johnson & Johnson — Talvey FDA Review (BLA761342, ORIG 1, 2023)Johnson & Johnson · 2023
- Bristol-Myers Squibb Company — Opdivo FDA Review (NDA/BLA 125554, 2023)Bristol-Myers Squibb Company · 2023
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2023)Merck & Co., Inc. · 2023
- AbbVie Inc. — Tepkinly EMA EPAR public assessment report (EMEA/H/C/005985, 2023)AbbVie Inc. · 2023
- Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public assessment report (EMEA/H/C/005910, 2023)Daiichi Sankyo Company, Limited · 2023
- Roche Holding AG — Columvi EMA EPAR variation assessment report (EMEA/H/C/005751, 2023)Roche Holding AG · 2023
- DAIICHI SANKYO — Enhertu FDA Review (NDA/BLA 761139, 2023)Daiichi Sankyo Company, Limited · 2023
- Bristol-Myers Squibb Company — Opdivo FDA Review (NDA/BLA 125554, 2023)Bristol-Myers Squibb Company · 2023
- Astellas Pharma Inc. — Padcev EMA EPAR variation assessment report (EMEA/H/C/005392, 2022)Astellas Pharma Inc. · 2022
- Bristol-Myers Squibb Company — Krazati FDA Review (NDA216340, ORIG 1, 2022)Bristol-Myers Squibb Company · 2022
- Oncopeptides — Pepaxti EMA EPAR variation assessment report (EMEA/H/C/005681, 2022)Oncopeptides · 2022
- Roche Holding AG — Lunsumio EMA EPAR variation assessment report (EMEA/H/C/005680, 2022)Roche Holding AG · 2022
- Astellas Pharma Inc. — Padcev EMA EPAR public assessment report (EMEA/H/C/005392, 2022)Astellas Pharma Inc. · 2022
- Bristol-Myers Squibb Company — Opdualag EMA EPAR public assessment report (EMEA/H/C/005481, 2022)Bristol-Myers Squibb Company · 2022
- Bristol-Myers Squibb Company — Opdualag EMA EPAR variation assessment report (EMEA/H/C/005481, 2022)Bristol-Myers Squibb Company · 2022
- Unknown MAH — Tecvayli EMA EPAR public assessment report (EMEA/H/C/005865, 2022)Johnson & Johnson · 2022
- Oncopeptides — Pepaxti EMA EPAR public assessment report (EMEA/H/C/005681, 2022)Oncopeptides · 2022
- Accord S L U — Zolsketil pegylated liposomal EMA EPAR public assessment report (EMEA/H/C/005320, 2022)Accord S L U · 2022
- Roche Holding AG — Lunsumio EMA EPAR public assessment report (EMEA/H/C/005680, 2022)Roche Holding AG · 2022
- Astellas Pharma Inc. — Padcev EMA EPAR variation assessment report (EMEA/H/C/005392, 2022)Astellas Pharma Inc. · 2022
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022)Bristol-Myers Squibb Company · 2022
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022)Bristol-Myers Squibb Company · 2022
- Amgen Inc. — Lumykras EMA EPAR public assessment report (EMEA/H/C/005522, 2022)Amgen Inc. · 2022
- GENENTECH — Avastin FDA Review (NDA/BLA 125085, 2022)Roche Holding AG · 2022
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022)Bristol-Myers Squibb Company · 2022
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022)Bristol-Myers Squibb Company · 2022
- Merck B V — Tepmetko EMA EPAR public assessment report (EMEA/H/C/005524, 2022)Merck B V · 2022
- Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessment report (EMEA/H/C/005685, 2022)Swedish Orphan Biovitrum · 2022
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR public assessment report (EMEA/H/C/004731, 2022)Bristol-Myers Squibb Company · 2022
- Immunocore — Kimmtrak EMA EPAR public assessment report (EMEA/H/C/004929, 2022)Immunocore · 2022
- Johnson & Johnson — Carvykti EMA EPAR variation assessment report (EMEA/H/C/005095, 2022)Johnson & Johnson · 2022
- Novartis AG — Tabrecta EMA EPAR public assessment report (EMEA/H/C/004845, 2022)Novartis AG · 2022
- Johnson & Johnson — Carvykti EMA EPAR public assessment report (EMEA/H/C/005095, 2022)Johnson & Johnson · 2022
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2022)Merck & Co., Inc. · 2022
- Stemline B V — Nexpovio EMA EPAR variation assessment report (EMEA/H/C/005127, 2021)Stemline B V · 2021
- AstraZeneca PLC — Koselugo EMA EPAR public assessment report (EMEA/H/C/005244, 2021)AstraZeneca PLC · 2021
- Stemline B V — Elzonris EMA EPAR public assessment report (EMEA/H/C/005031, 2021)Stemline B V · 2021
- GSK plc — Jemperli EMA EPAR public assessment report (EMEA/H/C/005204, 2021)GSK plc · 2021
- GSK plc — Jemperli EMA EPAR variation assessment report (EMEA/H/C/005204, 2021)GSK plc · 2021
- Bristol-Myers Squibb Company — Abecma EMA EPAR public assessment report (EMEA/H/C/004662, 2021)Bristol-Myers Squibb Company · 2021
- Stemline B V — Nexpovio EMA EPAR public assessment report (EMEA/H/C/005127, 2021)Stemline B V · 2021
- Incyte Corporation — Pemazyre EMA EPAR public assessment report (EMEA/H/C/005266, 2021)Incyte Corporation · 2021
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2021)Bristol-Myers Squibb Company · 2021
- Incyte Corporation — Minjuvi EMA EPAR variation assessment report (EMEA/H/C/005436, 2021)Incyte Corporation · 2021
- Pfizer Inc. — Tukysa EMA EPAR public assessment report (EMEA/H/C/005263, 2021)Pfizer Inc. · 2021
- Bristol-Myers Squibb Company — Abecma EMA EPAR variation assessment report (EMEA/H/C/004662, 2021)Bristol-Myers Squibb Company · 2021
- Gilead Sciences, Inc. — Trodelvy EMA EPAR public assessment report (EMEA/H/C/005182, 2021)Gilead Sciences, Inc. · 2021
- Unknown MAH — Rybrevant EMA EPAR public assessment report (EMEA/H/C/005454, 2021)Johnson & Johnson · 2021
- BeOne Medicines Ltd. — Brukinsa EMA EPAR public assessment report (EMEA/H/C/004978, 2021)BeOne Medicines Ltd. · 2021
- Gilead Sciences, Inc. — Trodelvy EMA EPAR variation assessment report (EMEA/H/C/005182, 2021)Gilead Sciences, Inc. · 2021
- Gilead Sciences, Inc. — Trodelvy EMA EPAR variation assessment report (EMEA/H/C/005182, 2021)Gilead Sciences, Inc. · 2021
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2021)Bristol-Myers Squibb Company · 2021
- BeOne Medicines Ltd. — Brukinsa EMA EPAR variation assessment report (EMEA/H/C/004978, 2021)BeOne Medicines Ltd. · 2021
- BeOne Medicines Ltd. — Brukinsa EMA EPAR variation assessment report (EMEA/H/C/004978, 2021)BeOne Medicines Ltd. · 2021
- Deciphera B V — Qinlock EMA EPAR public assessment report (EMEA/H/C/005614, 2021)Deciphera B V · 2021
- BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 2021)Bristol-Myers Squibb Company · 2021
- GENENTECH INC — Tecentriq FDA Review (NDA/BLA 761034, 2021)Roche Holding AG · 2021
- PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2021)AbbVie Inc. · 2021
- GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2021)Roche Holding AG · 2021
- GENENTECH — Avastin FDA Review (NDA/BLA 125085, 2021)Roche Holding AG · 2021
- TAIHO ONCOLOGY — Lonsurf FDA Review (NDA/BLA 207981, 2021)Otsuka Holdings Co., Ltd. · 2021
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2021)Merck & Co., Inc. · 2021
- IMCLONE — Erbitux FDA Review (NDA/BLA 125084, 2021)Eli Lilly and Company · 2021
- Incyte Corporation — Minjuvi EMA EPAR public assessment report (EMEA/H/C/005436, 2021)Incyte Corporation · 2021
- Unknown MAH — Rybrevant EMA EPAR variation assessment report (EMEA/H/C/005454, 2021)Johnson & Johnson · 2021
- Bristol-Myers Squibb Company — Onureg EMA EPAR public assessment report (EMEA/H/C/004761, 2021)Bristol-Myers Squibb Company · 2021
- GSK plc — Jemperli EMA EPAR variation assessment report (EMEA/H/C/005204, 2021)GSK plc · 2021
- Daiichi Sankyo Company, Limited — Enhertu EMA EPAR public assessment report (EMEA/H/C/005124, 2021)Daiichi Sankyo Company, Limited · 2021
- GSK plc — Jemperli EMA EPAR variation assessment report (EMEA/H/C/005204, 2021)GSK plc · 2021
- Unknown MAH — Rybrevant EMA EPAR variation assessment report (EMEA/H/C/005454, 2021)Unknown MAH · 2021
- Unknown MAH — Rybrevant EMA EPAR variation assessment report (EMEA/H/C/005454, 2021)Unknown MAH · 2021
- BeOne Medicines Ltd. — Brukinsa EMA EPAR variation assessment report (EMEA/H/C/004978, 2021)BeOne Medicines Ltd. · 2021
- Daiichi Sankyo Company, Limited — Enhertu EMA EPAR variation assessment report (EMEA/H/C/005124, 2021)Daiichi Sankyo Company, Limited · 2021
- Eli Lilly and Company — Retsevmo EMA EPAR public assessment report (EMEA/H/C/005375, 2021)Eli Lilly and Company · 2021
- Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021)Amgen Inc. · 2021
- Merck KGaA — Tepmetko FDA Review (NDA214096, ORIG 1, 2021)Merck KGaA · 2021
- SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2020)Sanofi · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2020)AbbVie Inc. · 2020
- Gilead Sciences, Inc. — Tecartus EMA EPAR variation assessment report (EMEA/H/C/005102, 2020)Gilead Sciences, Inc. · 2020
- EMD SERONO INC — Bavencio FDA Review (NDA/BLA 761049, 2020)Merck KGaA · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- AMGEN — Blincyto FDA Review (NDA/BLA 125557, 2020)Amgen Inc. · 2020
- Roche Holding AG — Phesgo EMA EPAR public assessment report (EMEA/H/C/005386, 2020)Roche Holding AG · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- MERCK SHARP DOHME — Keytruda FDA Summary Review (NDA/BLA 125514, 2020)Merck & Co., Inc. · 2020
- Gilead Sciences, Inc. — Tecartus EMA EPAR public assessment report (EMEA/H/C/005102, 2020)Gilead Sciences, Inc. · 2020
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2020)Merck & Co., Inc. · 2020
- Gilead Sciences, Inc. — Trodelvy FDA Review (BLA761115, ORIG 1, 2020)Gilead Sciences, Inc. · 2020
- ASTRAZENECA — Calquence FDA Review (NDA/BLA 210259, 2020)AstraZeneca PLC · 2020
- Unknown MAH — Phelinun EMA EPAR public assessment report (EMEA/H/C/005173, 2020)ADIENNE S.r.l. · 2020
- AstraZeneca PLC — Calquence EMA EPAR public assessment report (EMEA/H/C/005299, 2020)AstraZeneca PLC · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2020)Roche Holding AG · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)Bristol-Myers Squibb Company · 2020
- BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 2020)Bristol-Myers Squibb Company · 2020
- GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2020)Roche Holding AG · 2020
- ASTELLAS — Xospata FDA Review (NDA/BLA 211349, 2020)Astellas Pharma Inc. · 2020
- AbbVie Inc. — Venclexta FDA Review (NDA208573, SUPPL 20, 2020)AbbVie Inc. · 2020
- Pfizer Inc. — Tukysa FDA Review (NDA213411, ORIG 1, 2020)Pfizer Inc. · 2020
- Bayer Aktiengesellschaft — Nubeqa EMA EPAR variation assessment report (EMEA/H/C/004790, 2020)Bayer Aktiengesellschaft · 2020
- Sanofi — Sarclisa EMA EPAR public assessment report (EMEA/H/C/004977, 2020)Sanofi · 2020
- Blueprint Medicines B V — Ayvakyt EMA EPAR public assessment report (EMEA/H/C/005208, 2020)Blueprint Medicines B V · 2020
- Roche Holding AG — Rozlytrek EMA EPAR variation assessment report (EMEA/H/C/004936, 2020)Roche Holding AG · 2020
- SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2020)Sanofi · 2020
- Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORIG 1, 2019)Bayer Aktiengesellschaft · 2019
- BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019)Bayer Aktiengesellschaft · 2019
- ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019)Eli Lilly and Company · 2019
- ASTRAZENECA — Lynparza FDA Review (NDA/BLA 206162, 2019)AstraZeneca PLC · 2019
- ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019)AstraZeneca PLC · 2019
- Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1, 2019)Astellas Pharma Inc. · 2019
- NOVARTIS — Tafinlar FDA Review (NDA/BLA 202806, 2019)Novartis AG · 2019
- NOVARTIS — Kisqali FDA Review (NDA/BLA 209092, 2019)Novartis AG · 2019
- BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2019)Bristol-Myers Squibb Company · 2019
- BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2019)Bristol-Myers Squibb Company · 2019
- BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2019)Bristol-Myers Squibb Company · 2019
- BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2019)Bristol-Myers Squibb Company · 2019
- Daiichi Sankyo Company, Limited — Enhertu FDA Review (BLA761139, ORIG 1, 2019)Daiichi Sankyo Company, Limited · 2019
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2019)Merck & Co., Inc. · 2019
- SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2019)Sanofi · 2019
- ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019)AstraZeneca PLC · 2019
- ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019)AstraZeneca PLC · 2019
- PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019)Pfizer Inc. · 2019
- PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019)Pfizer Inc. · 2019
- AbbVie Inc. — Imbruvica FDA Review (NDA210563, ORIG 1, 2018)AbbVie Inc. · 2018
- PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2018)Pfizer Inc. · 2018
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2018)Bristol-Myers Squibb Company · 2018
- ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2018)AstraZeneca PLC · 2018
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2018)Bristol-Myers Squibb Company · 2018
- Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2018)Johnson & Johnson · 2018
- BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2018)Bristol-Myers Squibb Company · 2018
- JANSSEN BIOTECH — Zytiga FDA Review (NDA/BLA 202379, 2018)Johnson & Johnson · 2018
- Eli Lilly and Company — Verzenio FDA Review (NDA208716, ORIG 1, 2017)Eli Lilly and Company · 2017
- AstraZeneca PLC — Lynparza FDA Review (NDA208558, ORIG 1, 2017)AstraZeneca PLC · 2017
- Roche Holding AG — Alecensa EMA EPAR public assessment report (EMEA/H/C/004164, 2017)Roche Holding AG · 2017
- Roche Holding AG — Tecentriq EMA EPAR public assessment report (EMEA/H/C/004143, 2017)Roche Holding AG · 2017
- TAKEDA PHARMS USA — Velcade FDA Review (NDA/BLA 021602, 2017)Takeda Pharmaceutical Company Limited · 2017
- Helsinn Birex — Ledaga EMA EPAR public assessment report (EMEA/H/C/002826, 2017)Helsinn Birex · 2017
- Merck B V — Bavencio EMA EPAR public assessment report (EMEA/H/C/004338, 2017)Merck B V · 2017
- Recordati B V — Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) EMA EPAR public assessment report (EMEA/H/C/003918, 2017)Recordati B V · 2017
- Recordati B V — Fotivda EMA EPAR public assessment report (EMEA/H/C/004131, 2017)Recordati B V · 2017
- Merck B V — Bavencio EMA EPAR variation assessment report (EMEA/H/C/004338, 2017)Merck B V · 2017
- GSK plc — Zejula EMA EPAR public assessment report (EMEA/H/C/004249, 2017)GSK plc · 2017
- Novartis AG — Kisqali EMA EPAR public assessment report (EMEA/H/C/004213, 2017)Novartis AG · 2017
- AstraZeneca PLC — Imfinzi FDA Review (BLA761069, ORIG 1, 2017)AstraZeneca PLC · 2017
- Pfizer Inc. — Besponsa EMA EPAR public assessment report (EMEA/H/C/004119, 2017)Pfizer Inc. · 2017
- Roche Holding AG — Tecentriq EMA EPAR variation assessment report (EMEA/H/C/004143, 2017)Roche Holding AG · 2017
- Novartis AG — Rydapt EMA EPAR public assessment report (EMEA/H/C/004095, 2017)Novartis AG · 2017
- PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2017)AbbVie Inc. · 2017
- PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2017)AbbVie Inc. · 2017
- Pfizer Inc. — Besponsa EMA EPAR variation assessment report (EMEA/H/C/004119, 2017)Pfizer Inc. · 2017
- Novartis AG — Kisqali EMA EPAR variation assessment report (EMEA/H/C/004213, 2017)Novartis AG · 2017
- GENENTECH — Herceptin FDA Review (NDA/BLA 103792, 2017)Roche Holding AG · 2017
- Roche Holding AG — Alecensa EMA EPAR variation assessment report (EMEA/H/C/004164, 2017)Roche Holding AG · 2017
- Pfizer Inc. — Ibrance EMA EPAR variation assessment report (EMEA/H/C/003853, 2016)Pfizer Inc. · 2016
- JANSSEN BIOTECH — Zytiga FDA Review (NDA/BLA 202379, 2016)Johnson & Johnson · 2016
- HOFFMANN-LA ROCHE — Alecensa FDA Summary Review (NDA/BLA 208434, 2016)Roche Holding AG · 2016
- GENENTECH INC — Tecentriq FDA Summary Review (NDA/BLA 761041, 2016)Roche Holding AG · 2016
- SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2016)Sanofi · 2016
- Servier — Oncaspar EMA EPAR public assessment report (EMEA/H/C/003789, 2016)Servier · 2016
- GENENTECH INC — Tecentriq FDA Summary Review (NDA/BLA 761034, 2016)Roche Holding AG · 2016
- AstraZeneca PLC — Tagrisso EMA EPAR variation assessment report (EMEA/H/C/004124, 2016)AstraZeneca PLC · 2016
- Servier — Lonsurf EMA EPAR public assessment report (EMEA/H/C/003897, 2016)Servier · 2016
- Pfizer Inc. — Ibrance EMA EPAR public assessment report (EMEA/H/C/003853, 2016)Pfizer Inc. · 2016
- Servier — Onivyde pegylated liposomal (previously Onivyde) EMA EPAR variation assessment report (EMEA/H/C/004125, 2016)Servier · 2016
- Ipsen S.A. — Cabometyx EMA EPAR public assessment report (EMEA/H/C/004163, 2016)Ipsen S.A. · 2016
- Ipsen S.A. — Cabometyx EMA EPAR variation assessment report (EMEA/H/C/004163, 2016)Ipsen S.A. · 2016
- AbbVie Inc. — Venclyxto EMA EPAR public assessment report (EMEA/H/C/004106, 2016)AbbVie Inc. · 2016
- Takeda Pharmaceutical Company Limited — Ninlaro EMA EPAR public assessment report (EMEA/H/C/003844, 2016)Takeda Pharmaceutical Company Limited · 2016
- Servier — Onivyde pegylated liposomal (previously Onivyde) EMA EPAR public assessment report (EMEA/H/C/004125, 2016)Servier · 2016
- Eisai Co., Ltd. — Kisplyx EMA EPAR public assessment report (EMEA/H/C/004224, 2016)Eisai Co., Ltd. · 2016
- Unknown MAH — Darzalex EMA EPAR variation assessment report (EMEA/H/C/004077, 2016)Unknown MAH · 2016
- Bristol-Myers Squibb Company — Empliciti EMA EPAR public assessment report (EMEA/H/C/003967, 2016)Bristol-Myers Squibb Company · 2016
- PFIZER — Ibrance FDA Summary Review (NDA/BLA 207103, 2015)Pfizer Inc. · 2015
- ELI LILLY CO — Portrazza FDA Summary Review (NDA/BLA 125547, 2015)Eli Lilly and Company · 2015
- UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516, 2015)United Therapeutics Corporation · 2015
- Merck & Co., Inc. — Keytruda EMA EPAR public assessment report (EMEA/H/C/003820, 2015)Merck & Co., Inc. · 2015
- Sun Industries B V — Odomzo EMA EPAR public assessment report (EMEA/H/C/002839, 2015)Sun Industries B V · 2015
- Novartis AG — Zykadia EMA EPAR variation assessment report (EMEA/H/C/003819, 2015)Novartis AG · 2015
- Amgen Inc. — Blincyto EMA EPAR public assessment report (EMEA/H/C/003731, 2015)Amgen Inc. · 2015
- EISAI INC — Lenvima FDA Summary Review (NDA/BLA 206947, 2015)Eisai Co., Ltd. · 2015
- BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2015)Bristol-Myers Squibb Company · 2015
- BRISTOL MYERS SQUIBB — Opdivo FDA Summary Review (NDA/BLA 125554, 2015)Bristol-Myers Squibb Company · 2015
- AstraZeneca PLC — Tagrisso FDA Review (NDA208065, ORIG 1, 2015)AstraZeneca PLC · 2015
- ASTRAZENECA — Tagrisso FDA Summary Review (NDA/BLA 208065, 2015)AstraZeneca PLC · 2015
- TAIHO ONCOLOGY — Lonsurf FDA Summary Review (NDA/BLA 207981, 2015)Otsuka Holdings Co., Ltd. · 2015
- BRISTOL MYERS SQUIBB — Empliciti FDA Summary Review (NDA/BLA 761035, 2015)Bristol-Myers Squibb Company · 2015
- JANSSEN PRODS — Yondelis FDA Summary Review (NDA/BLA 207953, 2015)Johnson & Johnson · 2015
- PHARMACYCLICS LLC — Imbruvica FDA Summary Review (NDA/BLA 205552, 2015)AbbVie Inc. · 2015
- Merck & Co., Inc. — Keytruda EMA EPAR variation assessment report (EMEA/H/C/003820, 2015)Merck & Co., Inc. · 2015
- Novartis AG — Zykadia EMA EPAR public assessment report (EMEA/H/C/003819, 2015)Novartis AG · 2015
- SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015)Secura Bio · 2015
- JANSSEN BIOTECH — Darzalex FDA Summary Review (NDA/BLA 761036, 2015)Johnson & Johnson · 2015
- TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 208462, 2015)Takeda Pharmaceutical Company Limited · 2015
- Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1, 2015)Johnson & Johnson · 2015
- GENENTECH INC — Cotellic FDA Summary Review (NDA/BLA 206192, 2015)Roche Holding AG · 2015
- Novartis AG — Mekinist EMA EPAR variation assessment report (EMEA/H/C/002643, 2014)Novartis AG · 2014
- Roche Holding AG — Gazyvaro EMA EPAR public assessment report (EMEA/H/C/002799, 2014)Roche Holding AG · 2014
- Roche Holding AG — Gazyvaro EMA EPAR variation assessment report (EMEA/H/C/002799, 2014)Roche Holding AG · 2014
- Ipsen S.A. — Cometriq EMA EPAR public assessment report (EMEA/H/C/002640, 2014)Ipsen S.A. · 2014
- Boehringer Ingelheim — Giotrif EMA EPAR public assessment report (EMEA/H/C/002280, 2013)Boehringer Ingelheim · 2013
- Boehringer Ingelheim — Giotrif EMA EPAR variation assessment report (EMEA/H/C/002280, 2013)Boehringer Ingelheim · 2013
- Roche Holding AG — Perjeta EMA EPAR variation assessment report (EMEA/H/C/002547, 2013)Roche Holding AG · 2013
- Novartis AG — Tafinlar EMA EPAR public assessment report (EMEA/H/C/002604, 2013)Novartis AG · 2013
- Novartis AG — Tafinlar EMA EPAR variation assessment report (EMEA/H/C/002604, 2013)Novartis AG · 2013
- Roche Holding AG — Erivedge EMA EPAR public assessment report (EMEA/H/C/002602, 2013)Roche Holding AG · 2013
- Roche Holding AG — Erivedge EMA EPAR variation assessment report (EMEA/H/C/002602, 2013)Roche Holding AG · 2013
- Bayer Aktiengesellschaft — Stivarga EMA EPAR public assessment report (EMEA/H/C/002573, 2013)Bayer Aktiengesellschaft · 2013
- Bayer Aktiengesellschaft — Stivarga EMA EPAR variation assessment report (EMEA/H/C/002573, 2013)Bayer Aktiengesellschaft · 2013
- Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EMEA/H/C/002639, 2013)Astellas Pharma Inc. · 2013
- Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EMEA/H/C/002639, 2013)Astellas Pharma Inc. · 2013
- Roche Holding AG — Perjeta EMA EPAR variation assessment report (EMEA/H/C/002547, 2013)Roche Holding AG · 2013
- Roche Holding AG — Perjeta EMA EPAR public assessment report (EMEA/H/C/002547, 2013)Roche Holding AG · 2013
- Astellas Pharma Inc. — Xtandi EMA EPAR public assessment report (EMEA/H/C/002639, 2013)Astellas Pharma Inc. · 2013
- Roche Holding AG — Kadcyla EMA EPAR variation assessment report (EMEA/H/C/002389, 2013)Roche Holding AG · 2013
- Sanofi — Zaltrap EMA EPAR public assessment report (EMEA/H/C/002532, 2013)Sanofi · 2013
- Roche Holding AG — Kadcyla EMA EPAR public assessment report (EMEA/H/C/002389, 2013)Roche Holding AG · 2013
- Pfizer Inc. — Inlyta EMA EPAR public assessment report (EMEA/H/C/002406, 2012)Pfizer Inc. · 2012
- Unknown MAH — Dacogen EMA EPAR public assessment report (EMEA/H/C/002221, 2012)Unknown MAH · 2012
- Unknown MAH — Dacogen EMA EPAR variation assessment report (EMEA/H/C/002221, 2012)Unknown MAH · 2012
- Esteve S A — Caprelsa EMA EPAR public assessment report (EMEA/H/C/002315, 2012)Esteve S A · 2012
- Esteve S A — Caprelsa EMA EPAR variation assessment report (EMEA/H/C/002315, 2012)Esteve S A · 2012
- Roche Holding AG — Zelboraf EMA EPAR variation assessment report (EMEA/H/C/002409, 2012)Roche Holding AG · 2012
- Roche Holding AG — Zelboraf EMA EPAR public assessment report (EMEA/H/C/002409, 2012)Roche Holding AG · 2012
- Takeda Pharmaceutical Company Limited — Adcetris EMA EPAR variation assessment report (EMEA/H/C/002455, 2012)Takeda Pharmaceutical Company Limited · 2012
- Takeda Pharmaceutical Company Limited — Adcetris EMA EPAR public assessment report (EMEA/H/C/002455, 2012)Takeda Pharmaceutical Company Limited · 2012
- Pfizer Inc. — Xalkori EMA EPAR public assessment report (EMEA/H/C/002489, 2012)Pfizer Inc. · 2012
- Takeda Pharmaceutical Company Limited — Adcetris EMA EPAR variation assessment report (EMEA/H/C/002455, 2012)Takeda Pharmaceutical Company Limited · 2012
- Takeda Pharmaceutical Company Limited — Adcetris EMA EPAR variation assessment report (EMEA/H/C/002455, 2012)Takeda Pharmaceutical Company Limited · 2012
- Bristol-Myers Squibb Company — Yervoy EMA EPAR public assessment report (EMEA/H/C/002213, 2011)Bristol-Myers Squibb Company · 2011
- Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C/002018, 2011)Sanofi · 2011
- Johnson & Johnson — Zytiga EMA EPAR public assessment report (EMEA/H/C/002321, 2011)Johnson & Johnson · 2011
- Eisai Co., Ltd. — Halaven EMA EPAR public assessment report (EMEA/H/C/002084, 2011)Eisai Co., Ltd. · 2011
- Nordic B V — Teysuno EMA EPAR public assessment report (EMEA/H/C/001242, 2011)Nordic B V · 2011
- Johnson & Johnson — Zytiga EMA EPAR variation assessment report (EMEA/H/C/002321, 2011)Johnson & Johnson · 2011
- Bristol-Myers Squibb Company — Yervoy EMA EPAR variation assessment report (EMEA/H/C/002213, 2011)Bristol-Myers Squibb Company · 2011
- Nordic B V — Teysuno EMA EPAR variation assessment report (EMEA/H/C/001242, 2011)Nordic B V · 2011
- Eisai Co., Ltd. — Halaven EMA EPAR variation assessment report (EMEA/H/C/002084, 2011)Eisai Co., Ltd. · 2011
- Unknown MAH — Tepadina EMA EPAR public assessment report (EMEA/H/C/001046, 2010)Unknown MAH · 2010
- Novartis AG — Votrient EMA EPAR variation assessment report (EMEA/H/C/001141, 2010)Novartis AG · 2010
- Novartis AG — Votrient EMA EPAR public assessment report (EMEA/H/C/001141, 2010)Novartis AG · 2010
- Novartis AG — Afinitor EMA EPAR variation assessment report (EMEA/H/C/001038, 2009)Novartis AG · 2009
- Pierre Fabre Medicament — Javlor EMA EPAR variation assessment report (EMEA/H/C/000983, 2009)Pierre Fabre Medicament · 2009
- Novartis AG — Afinitor EMA EPAR public assessment report (EMEA/H/C/001038, 2009)Novartis AG · 2009
- Ferring A S — Firmagon EMA EPAR variation assessment report (EMEA/H/C/000986, 2009)Ferring A S · 2009
- Pierre Fabre Medicament — Javlor EMA EPAR public assessment report (EMEA/H/C/000983, 2009)Pierre Fabre Medicament · 2009
- Bristol-Myers Squibb Company — Abraxane EMA EPAR variation assessment report (EMEA/H/C/000778, 2008)Bristol-Myers Squibb Company · 2008
- Bristol-Myers Squibb Company — Vidaza EMA EPAR public assessment report (EMEA/H/C/000978, 2008)Bristol-Myers Squibb Company · 2008
- Novartis AG — Tyverb EMA EPAR public assessment report (EMEA/H/C/000795, 2008)Novartis AG · 2008
- Novartis AG — Tyverb EMA EPAR variation assessment report (EMEA/H/C/000795, 2008)Novartis AG · 2008
- Bristol-Myers Squibb Company — Abraxane EMA EPAR public assessment report (EMEA/H/C/000778, 2008)Bristol-Myers Squibb Company · 2008
- Amgen Inc. — Vectibix EMA EPAR variation assessment report (EMEA/H/C/000741, 2007)Amgen Inc. · 2007
- Amgen Inc. — Vectibix EMA EPAR variation assessment report (EMEA/H/C/000741, 2007)Amgen Inc. · 2007
- Mar S A — Yondelis EMA EPAR variation assessment report (EMEA/H/C/000773, 2007)Mar S A · 2007
- Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assessment report (EMEA/H/C/000690, 2006)Bayer Aktiengesellschaft · 2006
- Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/H/C/000613, 2006)Sanofi · 2006
- Pfizer Inc. — Sutent EMA EPAR variation assessment report (EMEA/H/C/000687, 2006)Pfizer Inc. · 2006
- Bristol-Myers Squibb Company — Sprycel EMA EPAR variation assessment report (EMEA/H/C/000709, 2006)Bristol-Myers Squibb Company · 2006
- Pfizer Inc. — Sutent EMA EPAR variation assessment report (EMEA/H/C/000687, 2006)Pfizer Inc. · 2006
- Roche Holding AG — Avastin EMA EPAR variation assessment report (EMEA/H/C/000582, 2005)Roche Holding AG · 2005
- Roche Holding AG — Avastin EMA EPAR variation assessment report (EMEA/H/C/000582, 2005)Roche Holding AG · 2005
- Cheplapharm — Tarceva EMA EPAR variation assessment report (EMEA/H/C/000618, 2005)Cheplapharm · 2005
- Cheplapharm — Tarceva EMA EPAR variation assessment report (EMEA/H/C/000618, 2005)Cheplapharm · 2005
- Cheplapharm — Tarceva EMA EPAR variation assessment report (EMEA/H/C/000618, 2005)Cheplapharm · 2005
- AstraZeneca PLC — Faslodex EMA EPAR public assessment report (EMEA/H/C/000540, 2004)AstraZeneca PLC · 2004
- Eli Lilly and Company — Alimta EMA EPAR variation assessment report (EMEA/H/C/000564, 2004)Eli Lilly and Company · 2004
- Merck B V — Erbitux EMA EPAR variation assessment report (EMEA/H/C/000558, 2004)Merck B V · 2004
- Merck B V — Erbitux EMA EPAR variation assessment report (EMEA/H/C/000558, 2004)Merck B V · 2004
- Esteve S A — Lysodren EMA EPAR variation assessment report (EMEA/H/C/000521, 2004)Esteve S A · 2004
- Johnson & Johnson — Velcade EMA EPAR variation assessment report (EMEA/H/C/000539, 2004)Johnson & Johnson · 2004
- Johnson & Johnson — Velcade EMA EPAR variation assessment report (EMEA/H/C/000539, 2004)Johnson & Johnson · 2004
- AstraZeneca PLC — Faslodex EMA EPAR variation assessment report (EMEA/H/C/000540, 2004)AstraZeneca PLC · 2004
- AstraZeneca PLC — Faslodex EMA EPAR variation assessment report (EMEA/H/C/000540, 2004)AstraZeneca PLC · 2004
- AstraZeneca PLC — Faslodex EMA EPAR variation assessment report (EMEA/H/C/000540, 2004)AstraZeneca PLC · 2004
- Teva B V — Trisenox EMA EPAR variation assessment report (EMEA/H/C/000388, 2002)Teva B V · 2002
- Teva B V — Trisenox EMA EPAR variation assessment report (EMEA/H/C/000388, 2002)Teva B V · 2002
- Cheplapharm — Xeloda EMA EPAR variation assessment report (EMEA/H/C/000316, 2001)Cheplapharm · 2001
- Cheplapharm — Xeloda EMA EPAR variation assessment report (EMEA/H/C/000316, 2001)Cheplapharm · 2001
- Novartis AG — Glivec EMA EPAR variation assessment report (EMEA/H/C/000406, 2001)Novartis AG · 2001
- Cheplapharm — Xeloda EMA EPAR variation assessment report (EMEA/H/C/000316, 2001)Cheplapharm · 2001
- H A C — Targretin EMA EPAR public assessment report (EMEA/H/C/000326, 2001)H A C · 2001
- Roche Holding AG — Herceptin EMA EPAR variation assessment report (EMEA/H/C/000278, 2000)Roche Holding AG · 2000
- Roche Holding AG — Herceptin EMA EPAR variation assessment report (EMEA/H/C/000278, 2000)Roche Holding AG · 2000
- Roche Holding AG — MabThera EMA EPAR variation assessment report (EMEA/H/C/000165, 1998)Roche Holding AG · 1998
- Sanofi — Taxotere EMA EPAR variation assessment report (EMEA/H/C/000073, 1995)Sanofi · 1995
- NOVO — Ozempic FDA Review (NDA/BLA 209637, 2026)NOVO · 2026
- NOVO — Fiasp FDA Review (NDA/BLA 208751, 2026)NOVO · 2026
- PROVENTION BIO INC — Tzield FDA Review (BLA761183, SUPPL 10, 2026)PROVENTION BIO INC · 2026
- Novo Nordisk A S — Kayshild EMA EPAR public assessment report (EMEA/H/C/006426, 2026)Novo Nordisk A S · 2026
- Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/C/005496, 2026)Sanofi · 2026
- NOVO — Ozempic FDA Review (NDA/BLA 209637, 2026)NOVO · 2026
- ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/BLA 217806, 2026)Eli Lilly and Company · 2026
- NOVO — Wegovy FDA Review (NDA/BLA 215256, 2026)NOVO · 2026
- Novo Nordisk A S — Kyinsu EMA EPAR public assessment report (EMEA/H/C/006279, 2025)Novo Nordisk A S · 2025
- Novo Nordisk A S — Awiqli EMA EPAR public assessment report (EMEA/H/C/005978, 2024)Novo Nordisk A S · 2024
- NOVO — Wegovy FDA Review (NDA/BLA 215256, 2024)NOVO · 2024
- ELI LILLY AND CO — Mounjaro (Autoinjector) FDA Review (NDA/BLA 215866, 2024)Eli Lilly and Company · 2024
- Eli Lilly and Company — Zepbound FDA Review (NDA217806, ORIG 1, 2023)Eli Lilly and Company · 2023
- ASTRAZENECA AB — Farxiga FDA Review (NDA/BLA 202293, 2023)AstraZeneca PLC · 2023
- Eli Lilly and Company — Mounjaro FDA Review (NDA215866, ORIG 1, 2022)Eli Lilly and Company · 2022
- Novo Nordisk A S — Wegovy EMA EPAR variation assessment report (EMEA/H/C/005422, 2022)Novo Nordisk A S · 2022
- Eli Lilly and Company — Mounjaro EMA EPAR variation assessment report (EMEA/H/C/005620, 2022)Eli Lilly and Company · 2022
- Eli Lilly and Company — Mounjaro EMA EPAR public assessment report (EMEA/H/C/005620, 2022)Eli Lilly and Company · 2022
- Novo Nordisk A S — Wegovy EMA EPAR public assessment report (EMEA/H/C/005422, 2022)Novo Nordisk A S · 2022
- JANSSEN PHARMS — Invokana FDA Review (NDA/BLA 204042, 2021)Johnson & Johnson · 2021
- Rhythm B V — Imcivree EMA EPAR public assessment report (EMEA/H/C/005089, 2021)Rhythm B V · 2021
- BOEHRINGER INGELHEIM — Jardiance FDA Review (NDA/BLA 204629, 2021)Boehringer Ingelheim · 2021
- BOEHRINGER INGELHEIM — Glyxambi FDA Review (NDA/BLA 206073, 2021)Boehringer Ingelheim · 2021
- BOEHRINGER INGELHEIM — Glyxambi FDA Review (NDA/BLA 206073, 2021)Boehringer Ingelheim · 2021
- Rhythm B V — Imcivree EMA EPAR variation assessment report (EMEA/H/C/005089, 2021)Rhythm B V · 2021
- ASTRAZENECA AB — Farxiga FDA Review (NDA/BLA 202293, 2021)AstraZeneca PLC · 2021
- AstraZeneca PLC — Farxiga FDA Review (NDA202293, SUPPL 24, 2021)AstraZeneca PLC · 2021
- ASTRAZENECA AB — Farxiga FDA Review (NDA/BLA 202293, 2021)AstraZeneca PLC · 2021
- SANOFI AVENTIS US — Lantus FDA Review (NDA/BLA 021081, 2020)Sanofi · 2020
- LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020)Eli Lilly and Company · 2020
- NOVO NORDISK INC — Victoza FDA Review (NDA/BLA 022341, 2020)NOVO NORDISK INC · 2020
- Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPAR public assessment report (EMEA/H/C/005037, 2020)Eli Lilly and Company · 2020
- JANSSEN PHARMS — Invokana FDA Review (NDA/BLA 204042, 2020)Johnson & Johnson · 2020
- SANOFI-AVENTIS US — Soliqua 100/33 FDA Summary Review (NDA/BLA 208673, 2020)Sanofi · 2020
- Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPAR variation assessment report (EMEA/H/C/005037, 2020)Eli Lilly and Company · 2020
- Novo Nordisk A S — Rybelsus EMA EPAR public assessment report (EMEA/H/C/004953, 2020)Novo Nordisk A S · 2020
- SANOFI AVENTIS US — Apidra FDA Review (NDA/BLA 021629, 2020)Sanofi · 2020
- NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020)NOVO NORDISK INC · 2020
- RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020)RHYTHM · 2020
- NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020)NOVO NORDISK INC · 2020
- NOVO — Ozempic FDA Review (NDA213051, ORIG 1, 2019)NOVO · 2019
- NOVO — Semaglutide FDA Review (NDA213051, ORIG 1, 2019)NOVO · 2019
- NOVO — Rybelsus FDA Review (NDA213051, ORIG 1, 2019)NOVO · 2019
- Johnson & Johnson — Invokana FDA Review (NDA204042, SUPPL 32, 2019)Johnson & Johnson · 2019
- NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019)NOVO · 2019
- Novo Nordisk A S — Ozempic EMA EPAR variation assessment report (EMEA/H/C/004174, 2018)Novo Nordisk A S · 2018
- Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/C/004379, 2018)Ammtek · 2018
- Merck & Co., Inc. — Steglatro EMA EPAR public assessment report (EMEA/H/C/004315, 2018)Merck & Co., Inc. · 2018
- Merck & Co., Inc. — Steglatro EMA EPAR variation assessment report (EMEA/H/C/004315, 2018)Merck & Co., Inc. · 2018
- Novo Nordisk A S — Ozempic EMA EPAR public assessment report (EMEA/H/C/004174, 2018)Novo Nordisk A S · 2018
- Merck & Co., Inc. — Steglujan EMA EPAR public assessment report (EMEA/H/C/004313, 2018)Merck & Co., Inc. · 2018
- Merck & Co., Inc. — Segluromet EMA EPAR public assessment report (EMEA/H/C/004314, 2018)Merck & Co., Inc. · 2018
- Merck & Co., Inc. — Segluromet EMA EPAR variation assessment report (EMEA/H/C/004314, 2018)Merck & Co., Inc. · 2018
- NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018)NOVO · 2018
- BOEHRINGER INGELHEIM — Jentadueto Xr FDA Summary Review (NDA/BLA 208026, 2017)Boehringer Ingelheim · 2017
- Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C/004243, 2017)Sanofi · 2017
- Boehringer Ingelheim — Jardiance FDA Review (NDA204629, SUPPL 5, 2016)Boehringer Ingelheim · 2016
- Boehringer Ingelheim — Glyxambi EMA EPAR public assessment report (EMEA/H/C/003833, 2016)Boehringer Ingelheim · 2016
- Astra Zeneca — Qtern EMA EPAR public assessment report (EMEA/H/C/004057, 2016)Astra Zeneca · 2016
- Boehringer Ingelheim — Synjardy FDA Review (NDA206111, ORIG 1, 2015)Boehringer Ingelheim · 2015
- Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H/C/003687, 2015)Orexigen · 2015
- Boehringer Ingelheim — Synjardy EMA EPAR variation assessment report (EMEA/H/C/003770, 2015)Boehringer Ingelheim · 2015
- Boehringer Ingelheim — Synjardy EMA EPAR public assessment report (EMEA/H/C/003770, 2015)Boehringer Ingelheim · 2015
- AstraZeneca PLC — Ebymect EMA EPAR public assessment report (EMEA/H/C/004162, 2015)AstraZeneca PLC · 2015
- AstraZeneca PLC — Edistride EMA EPAR variation assessment report (EMEA/H/C/004161, 2015)AstraZeneca PLC · 2015
- ASTRAZENECA AB — Xigduo Xr FDA Summary Review (NDA/BLA 205649, 2015)AstraZeneca PLC · 2015
- MSD — Januvia FDA Review (NDA/BLA 021995, 2015)MSD · 2015
- AstraZeneca PLC — Edistride EMA EPAR public assessment report (EMEA/H/C/004161, 2015)AstraZeneca PLC · 2015
- MSD — Januvia FDA Review (NDA/BLA 021995, 2015)MSD · 2015
- AstraZeneca PLC — Ebymect EMA EPAR variation assessment report (EMEA/H/C/004162, 2015)AstraZeneca PLC · 2015
- Novo Nordisk A S — Saxenda EMA EPAR variation assessment report (EMEA/H/C/003780, 2015)Novo Nordisk A S · 2015
- Novo Nordisk A S — Saxenda EMA EPAR public assessment report (EMEA/H/C/003780, 2015)Novo Nordisk A S · 2015
- Orexigen — Mysimba EMA EPAR variation assessment report (EMEA/H/C/003687, 2015)Orexigen · 2015
- Eli Lilly and Company — Trulicity EMA EPAR public assessment report (EMEA/H/C/002825, 2014)Eli Lilly and Company · 2014
- Eli Lilly and Company — Trulicity EMA EPAR variation assessment report (EMEA/H/C/002825, 2014)Eli Lilly and Company · 2014
- Johnson & Johnson — Vokanamet EMA EPAR public assessment report (EMEA/H/C/002656, 2014)Johnson & Johnson · 2014
- Johnson & Johnson — Vokanamet EMA EPAR variation assessment report (EMEA/H/C/002656, 2014)Johnson & Johnson · 2014
- AstraZeneca PLC — Xigduo EMA EPAR public assessment report (EMEA/H/C/002672, 2014)AstraZeneca PLC · 2014
- AstraZeneca PLC — Xigduo EMA EPAR variation assessment report (EMEA/H/C/002672, 2014)AstraZeneca PLC · 2014
- Novo Nordisk A S — Xultophy EMA EPAR public assessment report (EMEA/H/C/002647, 2014)Novo Nordisk A S · 2014
- Novo Nordisk A S — Xultophy EMA EPAR variation assessment report (EMEA/H/C/002647, 2014)Novo Nordisk A S · 2014
- Boehringer Ingelheim — Jardiance EMA EPAR public assessment report (EMEA/H/C/002677, 2014)Boehringer Ingelheim · 2014
- Boehringer Ingelheim — Jardiance EMA EPAR variation assessment report (EMEA/H/C/002677, 2014)Boehringer Ingelheim · 2014
- Novo Nordisk A S — Ryzodeg EMA EPAR variation assessment report (EMEA/H/C/002499, 2013)Novo Nordisk A S · 2013
- Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report (EMEA/H/C/002499, 2013)Novo Nordisk A S · 2013
- Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR variation assessment report (EMEA/H/C/002182, 2013)Takeda Pharmaceutical Company Limited · 2013
- Johnson & Johnson — Invokana EMA EPAR variation assessment report (EMEA/H/C/002649, 2013)Johnson & Johnson · 2013
- Johnson & Johnson — Invokana EMA EPAR public assessment report (EMEA/H/C/002649, 2013)Johnson & Johnson · 2013
- Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR public assessment report (EMEA/H/C/002182, 2013)Takeda Pharmaceutical Company Limited · 2013
- Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR variation assessment report (EMEA/H/C/002654, 2013)Takeda Pharmaceutical Company Limited · 2013
- Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR public assessment report (EMEA/H/C/002654, 2013)Takeda Pharmaceutical Company Limited · 2013
- Takeda Pharmaceutical Company Limited — Incresync EMA EPAR public assessment report (EMEA/H/C/002178, 2013)Takeda Pharmaceutical Company Limited · 2013
- Novo Nordisk A S — Tresiba EMA EPAR variation assessment report (EMEA/H/C/002498, 2013)Novo Nordisk A S · 2013
- Novo Nordisk A S — Tresiba EMA EPAR public assessment report (EMEA/H/C/002498, 2013)Novo Nordisk A S · 2013
- Boehringer Ingelheim — Jentadueto EMA EPAR variation assessment report (EMEA/H/C/002279, 2012)Boehringer Ingelheim · 2012
- AstraZeneca PLC — Forxiga EMA EPAR public assessment report (EMEA/H/C/002322, 2012)AstraZeneca PLC · 2012
- Boehringer Ingelheim — Jentadueto EMA EPAR public assessment report (EMEA/H/C/002279, 2012)Boehringer Ingelheim · 2012
- AstraZeneca PLC — Komboglyze EMA EPAR public assessment report (EMEA/H/C/002059, 2011)AstraZeneca PLC · 2011
- AstraZeneca PLC — Bydureon EMA EPAR public assessment report (EMEA/H/C/002020, 2011)AstraZeneca PLC · 2011
- Boehringer Ingelheim — Trajenta EMA EPAR public assessment report (EMEA/H/C/002110, 2011)Boehringer Ingelheim · 2011
- Boehringer Ingelheim — Trajenta EMA EPAR variation assessment report (EMEA/H/C/002110, 2011)Boehringer Ingelheim · 2011
- AstraZeneca PLC — Komboglyze EMA EPAR variation assessment report (EMEA/H/C/002059, 2011)AstraZeneca PLC · 2011
- AstraZeneca PLC — Bydureon EMA EPAR variation assessment report (EMEA/H/C/002020, 2011)AstraZeneca PLC · 2011
- Merck & Co., Inc. — Ristfor EMA EPAR public assessment report (EMEA/H/C/001235, 2010)Merck & Co., Inc. · 2010
- Merck & Co., Inc. — Ristaben EMA EPAR public assessment report (EMEA/H/C/001234, 2010)Merck & Co., Inc. · 2010
- Merck & Co., Inc. — Ristaben EMA EPAR variation assessment report (EMEA/H/C/001234, 2010)Merck & Co., Inc. · 2010
- Merck & Co., Inc. — Ristfor EMA EPAR variation assessment report (EMEA/H/C/001235, 2010)Merck & Co., Inc. · 2010
- AMGEN INC — Otezla FDA Review (NDA/BLA 205437, 2026)Amgen Inc. · 2026
- JANSSEN BIOTECH — Tremfya FDA Review (NDA/BLA 761061, 2026)Johnson & Johnson · 2026
- REGENERON PHARMACEUTICALS — Dupixent FDA Review (NDA/BLA 761055, 2026)Regeneron Pharmaceuticals, Inc. · 2026
- ABBVIE INC — Humira FDA Review (NDA/BLA 125057, 2026)AbbVie Inc. · 2026
- CENTOCOR ORTHO BIOTECH INC — Simponi FDA Review (NDA/BLA 125289, 2026)CENTOCOR ORTHO BIOTECH INC · 2026
- Galderma — Nemluvio EMA EPAR variation assessment report (EMEA/H/C/006149, 2025)Galderma · 2025
- NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504, 2025)Novartis AG · 2025
- Amgen Inc. — Otezla FDA Review (NDA210745, ORIG 2, 2025)Amgen Inc. · 2025
- SAMSUNG BIOEPIS CO LTD — Pyzchiva FDA Summary Review (NDA/BLA 761373, 2025)SAMSUNG BIOEPIS CO LTD · 2025
- Johnson & Johnson — Imaavy EMA EPAR public assessment report (EMEA/H/C/006379, 2025)Johnson & Johnson · 2025
- Galderma — Nemluvio EMA EPAR public assessment report (EMEA/H/C/006149, 2025)Galderma · 2025
- NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504, 2025)Novartis AG · 2025
- UCB — Rystiggo EMA EPAR public assessment report (EMEA/H/C/005824, 2024)UCB · 2024
- ABBVIE INC — Skyrizi FDA Review (NDA/BLA 761105, 2024)AbbVie Inc. · 2024
- ABBVIE — Rinvoq FDA Review (NDA/BLA 211675, 2024)AbbVie Inc. · 2024
- AbbVie Inc. — Rinvoq FDA Review (NDA218347, ORIG 1, 2024)AbbVie Inc. · 2024
- Pfizer Inc. — Velsipity EMA EPAR public assessment report (EMEA/H/C/006007, 2024)Pfizer Inc. · 2024
- BRISTOL — Zeposia FDA Review (NDA/BLA 209899, 2023)Bristol-Myers Squibb Company · 2023
- Eli Lilly and Company — Omvoh EMA EPAR variation assessment report (EMEA/H/C/005122, 2023)Eli Lilly and Company · 2023
- Eli Lilly and Company — Omvoh EMA EPAR public assessment report (EMEA/H/C/005122, 2023)Eli Lilly and Company · 2023
- Takeda Pharmaceutical Company Limited — Entyvio FDA Review (BLA761133, ORIG 1, 2023)Takeda Pharmaceutical Company Limited · 2023
- JANSSEN BIOTECH — Tremfya FDA Review (NDA/BLA 761061, 2023)Johnson & Johnson · 2023
- UCB SA — Bimzelx FDA Review (BLA761151, ORIG 1, 2023)UCB SA · 2023
- AMGEN INC — Otezla FDA Review (NDA/BLA 205437, 2023)Amgen Inc. · 2023
- Almirall S A — Ebglyss EMA EPAR public assessment report (EMEA/H/C/005894, 2023)Almirall S A · 2023
- Eli Lilly and Company — Omvoh EMA EPAR variation assessment report (EMEA/H/C/005122, 2023)Eli Lilly and Company · 2023
- Bristol-Myers Squibb Company — Sotyktu EMA EPAR variation assessment report (EMEA/H/C/005755, 2023)Bristol-Myers Squibb Company · 2023
- Bristol-Myers Squibb Company — Sotyktu EMA EPAR public assessment report (EMEA/H/C/005755, 2023)Bristol-Myers Squibb Company · 2023
- Eli Lilly and Company — Omvoh FDA Review (BLA761279, ORIG 1, 2023)Eli Lilly and Company · 2023
- Pfizer Inc. — Velsipity FDA Review (NDA216956, ORIG 1, 2023)Pfizer Inc. · 2023
- REGENERON PHARMACEUTICALS — Dupixent FDA Review (NDA/BLA 761055, 2022)Regeneron Pharmaceuticals, Inc. · 2022
- Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022)Pfizer Inc. · 2022
- Bristol-Myers Squibb Company — Sotyktu FDA Review (NDA214958, ORIG 1, 2022)Bristol-Myers Squibb Company · 2022
- LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/C/005874, 2022)LEO A S · 2022
- Argenx — Vyvgart EMA EPAR public assessment report (EMEA/H/C/005849, 2022)Argenx · 2022
- Argenx — Vyvgart EMA EPAR variation assessment report (EMEA/H/C/005849, 2022)Argenx · 2022
- AstraZeneca PLC — Saphnelo EMA EPAR public assessment report (EMEA/H/C/004975, 2022)AstraZeneca PLC · 2022
- Argenx — Vyvgart EMA EPAR variation assessment report (EMEA/H/C/005849, 2022)Argenx · 2022
- ABBVIE INC — Skyrizi FDA Review (NDA/BLA 761105, 2022)AbbVie Inc. · 2022
- PF PRISM CV — Xeljanz FDA Review (NDA/BLA 203214, 2022)PF PRISM CV · 2022
- UCB S A — Bimzelx EMA EPAR public assessment report (EMEA/H/C/005316, 2021)UCB S A · 2021
- Pfizer Inc. — Cibinqo EMA EPAR public assessment report (EMEA/H/C/005452, 2021)Pfizer Inc. · 2021
- Pfizer Inc. — Cibinqo EMA EPAR variation assessment report (EMEA/H/C/005452, 2021)Pfizer Inc. · 2021
- UCB S A — Bimzelx EMA EPAR variation assessment report (EMEA/H/C/005316, 2021)UCB S A · 2021
- JANSSEN BIOTECH — Stelara FDA Review (NDA/BLA 761044, 2021)Johnson & Johnson · 2021
- UCB S A — Bimzelx EMA EPAR variation assessment report (EMEA/H/C/005316, 2021)UCB S A · 2021
- ABBVIE INC — Humira FDA Review (NDA/BLA 125057, 2021)AbbVie Inc. · 2021
- UCB INC — Cimzia FDA Review (NDA/BLA 125160, 2021)UCB INC · 2021
- Bristol-Myers Squibb Company — Zeposia EMA EPAR variation assessment report (EMEA/H/C/004835, 2020)Bristol-Myers Squibb Company · 2020
- Bristol-Myers Squibb Company — Zeposia EMA EPAR variation assessment report (EMEA/H/C/004835, 2020)Bristol-Myers Squibb Company · 2020
- Pfizer Inc. — Xeljanz FDA Review (NDA213082, ORIG 1, 2020)Pfizer Inc. · 2020
- Alfasigma S p A — Jyseleca EMA EPAR variation assessment report (EMEA/H/C/005113, 2020)Alfasigma S p A · 2020
- Alfasigma S p A — Jyseleca EMA EPAR public assessment report (EMEA/H/C/005113, 2020)Alfasigma S p A · 2020
- AbbVie Inc. — Rinvoq EMA EPAR variation assessment report (EMEA/H/C/004760, 2019)AbbVie Inc. · 2019
- AbbVie Inc. — Skyrizi EMA EPAR variation assessment report (EMEA/H/C/004759, 2019)AbbVie Inc. · 2019
- AbbVie Inc. — Skyrizi EMA EPAR variation assessment report (EMEA/H/C/004759, 2019)AbbVie Inc. · 2019
- AbbVie Inc. — Rinvoq EMA EPAR variation assessment report (EMEA/H/C/004760, 2019)AbbVie Inc. · 2019
- AbbVie Inc. — Skyrizi EMA EPAR public assessment report (EMEA/H/C/004759, 2019)AbbVie Inc. · 2019
- PF PRISM CV — Xeljanz FDA Review (NDA/BLA 203214, 2019)PF PRISM CV · 2019
- Regeneron Pharmaceuticals, Inc. — Dupixent FDA Review (BLA761055, SUPPL 14, 2019)Regeneron Pharmaceuticals, Inc. · 2019
- AbbVie Inc. — Rinvoq EMA EPAR variation assessment report (EMEA/H/C/004760, 2019)AbbVie Inc. · 2019
- AbbVie Inc. — Skyrizi FDA Review (BLA761105, ORIG 1, 2019)AbbVie Inc. · 2019
- CENTOCOR ORTHO BIOTECH INC — Stelara FDA Review (NDA/BLA 125261, 2019)CENTOCOR ORTHO BIOTECH INC · 2019
- AbbVie Inc. — Rinvoq EMA EPAR public assessment report (EMEA/H/C/004760, 2019)AbbVie Inc. · 2019
- JANSSEN BIOTECH — Simponi Aria FDA Review (NDA/BLA 125433, 2018)Johnson & Johnson · 2018
- Eli Lilly and Company — Olumiant FDA Review (NDA207924, ORIG 1, 2018)Eli Lilly and Company · 2018
- Roche Holding AG — Ocrevus EMA EPAR public assessment report (EMEA/H/C/004043, 2018)Roche Holding AG · 2018
- SANDOZ — Erelzi FDA Review (NDA/BLA 761042, 2018)Novartis AG · 2018
- Almirall S A — Ilumetri EMA EPAR public assessment report (EMEA/H/C/004514, 2018)Almirall S A · 2018
- Roche Holding AG — Ocrevus EMA EPAR variation assessment report (EMEA/H/C/004043, 2018)Roche Holding AG · 2018
- Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/C/003756, 2017)Oresund · 2017
- Sanofi — Dupixent EMA EPAR public assessment report (EMEA/H/C/004390, 2017)Sanofi · 2017
- Johnson & Johnson — Tremfya EMA EPAR public assessment report (EMEA/H/C/004271, 2017)Johnson & Johnson · 2017
- Johnson & Johnson — Tremfya EMA EPAR variation assessment report (EMEA/H/C/004271, 2017)Johnson & Johnson · 2017
- Sanofi — Kevzara EMA EPAR public assessment report (EMEA/H/C/004254, 2017)Sanofi · 2017
- Sanofi — Kevzara EMA EPAR variation assessment report (EMEA/H/C/004254, 2017)Sanofi · 2017
- Almirall S A — Skilarence EMA EPAR public assessment report (EMEA/H/C/002157, 2017)Almirall S A · 2017
- Pfizer Inc. — Xeljanz EMA EPAR public assessment report (EMEA/H/C/004214, 2017)Pfizer Inc. · 2017
- Pfizer Inc. — Xeljanz EMA EPAR variation assessment report (EMEA/H/C/004214, 2017)Pfizer Inc. · 2017
- Eli Lilly and Company — Olumiant EMA EPAR public assessment report (EMEA/H/C/004085, 2017)Eli Lilly and Company · 2017
- Sanofi — Dupixent EMA EPAR variation assessment report (EMEA/H/C/004390, 2017)Sanofi · 2017
- LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H/C/003959, 2017)LEO A S · 2017
- Johnson & Johnson — Tremfya FDA Review (BLA761061, ORIG 1, 2017)Johnson & Johnson · 2017
- Sanofi — Kevzara FDA Review (BLA761037, ORIG 1, 2017)Sanofi · 2017
- Eli Lilly and Company — Taltz EMA EPAR public assessment report (EMEA/H/C/003943, 2016)Eli Lilly and Company · 2016
- Johnson & Johnson — Stelara FDA Review (BLA761044, ORIG 1, 2016)Johnson & Johnson · 2016
- Nordic B V — Nordimet EMA EPAR variation assessment report (EMEA/H/C/003983, 2016)Nordic B V · 2016
- Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1, 2016)Eli Lilly and Company · 2016
- ELI LILLY AND CO — Taltz FDA Summary Review (NDA/BLA 125521, 2016)Eli Lilly and Company · 2016
- BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016)BIOGEN · 2016
- SANDOZ — Erelzi FDA Summary Review (NDA/BLA 761042, 2016)Novartis AG · 2016
- Eli Lilly and Company — Taltz EMA EPAR variation assessment report (EMEA/H/C/003943, 2016)Eli Lilly and Company · 2016
- Amgen Inc. — Otezla EMA EPAR public assessment report (EMEA/H/C/003746, 2015)Amgen Inc. · 2015
- AbbVie Inc. — Humira FDA Review (BLA125057, SUPPL 393, 2015)AbbVie Inc. · 2015
- Novartis AG — Cosentyx EMA EPAR variation assessment report (EMEA/H/C/003729, 2015)Novartis AG · 2015
- Amgen Inc. — Otezla EMA EPAR variation assessment report (EMEA/H/C/003746, 2015)Amgen Inc. · 2015
- Novartis AG — Cosentyx FDA Review (BLA125504, ORIG 1, 2015)Novartis AG · 2015
- Novartis AG — Cosentyx EMA EPAR public assessment report (EMEA/H/C/003729, 2015)Novartis AG · 2015
- Recordati B V — Sylvant EMA EPAR public assessment report (EMEA/H/C/003708, 2014)Recordati B V · 2014
- GSK plc — Benlysta EMA EPAR public assessment report (EMEA/H/C/002015, 2011)GSK plc · 2011
- Zentiva k s — Leflunomide Zentiva (previously Leflunomide Winthrop) EMA EPAR public assessment report (EMEA/H/C/001129, 2010)Zentiva k s · 2010
- Novartis AG — Itvisma EMA EPAR public assessment report (EMEA/H/C/006498, 2026)Novartis AG · 2026
- Tanabe — Onerji EMA EPAR public assessment report (EMEA/H/C/006429, 2026)Tanabe · 2026
- AKCEA THERAPS — Tegsedi FDA Review (NDA/BLA 211172, 2026)AKCEA THERAPS · 2026
- Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/006371, 2026)Teva · 2026
- Eli Lilly and Company — Kisunla EMA EPAR public assessment report (EMEA/H/C/006024, 2025)Eli Lilly and Company · 2025
- Roche Holding AG — Evrysdi FDA Review (NDA219285, ORIG 1, 2025)Roche Holding AG · 2025
- Eisai Co., Ltd. — Leqembi EMA EPAR public assessment report (EMEA/H/C/005966, 2025)Eisai Co., Ltd. · 2025
- AstraZeneca PLC — Wainzua EMA EPAR public assessment report (EMEA/H/C/006295, 2025)AstraZeneca PLC · 2025
- Eli Lilly and Company — Kisunla FDA Review (BLA761248, ORIG 1, 2024)Eli Lilly and Company · 2024
- EISAI INC — Leqembi FDA Review (NDA/BLA 761269, 2024)Eisai Co., Ltd. · 2024
- Biogen B V — Qalsody EMA EPAR public assessment report (EMEA/H/C/005493, 2024)Biogen B V · 2024
- AbbVie Inc. — Aquipta EMA EPAR public assessment report (EMEA/H/C/005871, 2023)AbbVie Inc. · 2023
- Eisai Co., Ltd. — Leqembi FDA Review (BLA761269, ORIG 1, 2023)Eisai Co., Ltd. · 2023
- EISAI INC — Leqembi FDA Summary Review (NDA/BLA 761269, 2023)Eisai Co., Ltd. · 2023
- AbbVie Inc. — Aquipta EMA EPAR variation assessment report (EMEA/H/C/005871, 2023)AbbVie Inc. · 2023
- Biogen Inc. — Qalsody FDA Review (NDA215887, ORIG 1, 2023)Biogen Inc. · 2023
- Marinus Emerald — Ztalmy EMA EPAR public assessment report (EMEA/H/C/005825, 2023)Marinus Emerald · 2023
- H Lundbeck A S — Vyepti EMA EPAR public assessment report (EMEA/H/C/005287, 2022)H Lundbeck A S · 2022
- JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022)JAZZ PHARMS · 2022
- Alnylam B V — Amvuttra EMA EPAR public assessment report (EMEA/H/C/005852, 2022)Alnylam B V · 2022
- Eli Lilly and Company — Rayvow EMA EPAR public assessment report (EMEA/H/C/005332, 2022)Eli Lilly and Company · 2022
- Pfizer Inc. — Vydura EMA EPAR public assessment report (EMEA/H/C/005725, 2022)Pfizer Inc. · 2022
- Alnylam B V — Amvuttra EMA EPAR variation assessment report (EMEA/H/C/005852, 2022)Alnylam B V · 2022
- NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022)NEUROCRINE · 2022
- Alnylam Pharmaceuticals, Inc. — Amvuttra FDA Review (NDA215515, ORIG 1, 2022)Alnylam Pharmaceuticals, Inc. · 2022
- TG THERAPEUTICS, INC — Briumvi FDA Review (BLA761238, ORIG 1, 2022)TG THERAPEUTICS, INC · 2022
- Angelini S p A — Ontozry EMA EPAR public assessment report (EMEA/H/C/005377, 2021)Angelini S p A · 2021
- Roche Holding AG — Evrysdi EMA EPAR public assessment report (EMEA/H/C/005145, 2021)Roche Holding AG · 2021
- Roche Holding AG — Evrysdi EMA EPAR variation assessment report (EMEA/H/C/005145, 2021)Roche Holding AG · 2021
- AbbVie Inc. — Atogepant FDA Review (NDA215206, ORIG 1, 2021)AbbVie Inc. · 2021
- Pfizer Inc. — Nurtec FDA Review (NDA212728, ORIG 1, 2020)Pfizer Inc. · 2020
- H. Lundbeck A/S — Vyepti FDA Review (BLA761119, ORIG 1, 2020)H. Lundbeck A/S · 2020
- UCB SA — Fintepla EMA EPAR variation assessment report (EMEA/H/C/003933, 2020)UCB SA · 2020
- Novartis AG — Kesimpta FDA Review (BLA125326, SUPPL 70, 2020)Novartis AG · 2020
- Jazz Pharmaceuticals plc — Xywav FDA Review (NDA212690, ORIG 1, 2020)Jazz Pharmaceuticals plc · 2020
- Novartis AG — Zolgensma EMA EPAR public assessment report (EMEA/H/C/004750, 2020)Novartis AG · 2020
- UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/C/003933, 2020)UCB SA · 2020
- HARMONY — Wakix FDA Review (NDA211150, ORIG 2, 2020)HARMONY · 2020
- Biogen Inc. — Vumerity FDA Review (NDA211855, ORIG 1, 2019)Biogen Inc. · 2019
- Jazz — Epidyolex EMA EPAR public assessment report (EMEA/H/C/004675, 2019)Jazz · 2019
- Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/004786, 2019)Merz · 2019
- Teva — Ajovy EMA EPAR public assessment report (EMEA/H/C/004833, 2019)Teva · 2019
- UCB SA — Lacosamide UCB EMA EPAR public assessment report (EMEA/H/C/005243, 2019)UCB SA · 2019
- AbbVie Inc. — Ubrelvy FDA Review (NDA211765, ORIG 1, 2019)AbbVie Inc. · 2019
- UCB SA — Lacosamide UCB EMA EPAR variation assessment report (EMEA/H/C/005243, 2019)UCB SA · 2019
- Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG 1, 2018)Eli Lilly and Company · 2018
- Akcea — Tegsedi EMA EPAR public assessment report (EMEA/H/C/004782, 2018)Akcea · 2018
- Novartis AG — Aimovig EMA EPAR variation assessment report (EMEA/H/C/004447, 2018)Novartis AG · 2018
- Alnylam B V — Onpattro EMA EPAR public assessment report (EMEA/H/C/004699, 2018)Alnylam B V · 2018
- Novartis AG — Aimovig EMA EPAR public assessment report (EMEA/H/C/004447, 2018)Novartis AG · 2018
- Orphelia S A S — Kigabeq EMA EPAR public assessment report (EMEA/H/C/004534, 2018)Orphelia S A S · 2018
- Teva Pharmaceutical Industries Limited — Ajovy FDA Review (BLA761089, ORIG 1, 2018)Teva Pharmaceutical Industries Limited · 2018
- Roche Holding AG — Ocrevus FDA Review (BLA761053, ORIG 1, 2017)Roche Holding AG · 2017
- NEUROCRINE — Ingrezza FDA Summary Review (NDA/BLA 209241, 2017)NEUROCRINE · 2017
- Teva Pharmaceutical Industries Limited — Austedo FDA Review (NDA208082, ORIG 1, 2017)Teva Pharmaceutical Industries Limited · 2017
- Bioprojet — Wakix EMA EPAR variation assessment report (EMEA/H/C/002616, 2016)Bioprojet · 2016
- SANDOZ — Exelon FDA Review (NDA/BLA 022083, 2016)Novartis AG · 2016
- Biogen Inc. — Spinraza FDA Review (NDA209531, ORIG 1, 2016)Biogen Inc. · 2016
- Bioprojet — Wakix EMA EPAR public assessment report (EMEA/H/C/002616, 2016)Bioprojet · 2016
- Bial Portela C S A — Ongentys EMA EPAR public assessment report (EMEA/H/C/002790, 2016)Bial Portela C S A · 2016
- UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public assessment report (EMEA/H/C/003898, 2016)UCB SA · 2016
- UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR variation assessment report (EMEA/H/C/003898, 2016)UCB SA · 2016
- Zambon — Xadago EMA EPAR public assessment report (EMEA/H/C/002396, 2015)Zambon · 2015
- Orion Corporation — Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) EMA EPAR public assessment report (EMEA/H/C/002785, 2013)Orion Corporation · 2013
- Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment report (EMEA/H/C/002434, 2012)Eisai Co., Ltd. · 2012
- Eisai Co., Ltd. — Fycompa EMA EPAR public assessment report (EMEA/H/C/002434, 2012)Eisai Co., Ltd. · 2012
- Pfizer Inc. — Vyndaqel EMA EPAR public assessment report (EMEA/H/C/002294, 2011)Pfizer Inc. · 2011
- Pfizer Inc. — Vyndaqel EMA EPAR variation assessment report (EMEA/H/C/002294, 2011)Pfizer Inc. · 2011
- Orion Corporation — Levodopa/Carbidopa/Entacapone Orion EMA EPAR public assessment report (EMEA/H/C/002441, 2011)Orion Corporation · 2011
- Merz — Fampyra EMA EPAR public assessment report (EMEA/H/C/002097, 2011)Merz · 2011
- Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/C/002097, 2011)Merz · 2011
- Biogen Inc. — Zurzuvae EMA EPAR public assessment report (EMEA/H/C/006488, 2026)Biogen Inc. · 2026
- Neuraxpharm — Tuzulby EMA EPAR variation assessment report (EMEA/H/C/005975, 2025)Neuraxpharm · 2025
- Neurocrine Biosciences, Inc. — Ingrezza FDA Review (NDA218390, ORIG 1, 2024)Neurocrine Biosciences, Inc. · 2024
- LUYE INNOMIND PHARMA — Erzofri FDA Review (NDA216352, ORIG 1, 2024)LUYE INNOMIND PHARMA · 2024
- Bristol-Myers Squibb Company — Cobenfy FDA Review (NDA216158, ORIG 1, 2024)Bristol-Myers Squibb Company · 2024
- Tris Pharma — Onyda Xr FDA Review (NDA217645, ORIG 1, 2024)Tris Pharma · 2024
- Otsuka Holdings Co., Ltd. — Rexulti FDA Review (NDA205422, SUPPL 9, 2023)Otsuka Holdings Co., Ltd. · 2023
- Braeburn — Brixadi FDA Review (NDA210136, ORIG 1, 2023)Braeburn · 2023
- Teva Pharmaceutical Industries Limited — Uzedy FDA Review (NDA213586, ORIG 1, 2023)Teva Pharmaceutical Industries Limited · 2023
- FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023)FABRE KRAMER · 2023
- Biogen Inc. — Zurzuvae FDA Review (NDA217369, ORIG 2, 2023)Biogen Inc. · 2023
- Braeburn — Brixadi FDA Review (NDA210136, ORIG 1, 2023)Braeburn · 2023
- Otsuka Holdings Co., Ltd. — Abilify Asimtufii FDA Review (NDA217006, ORIG 1, 2023)Otsuka Holdings Co., Ltd. · 2023
- SHANDONG LUYE — Rykindo FDA Review (NDA212849, ORIG 1, 2023)SHANDONG LUYE · 2023
- Axsome Therapeutics, Inc. — Auvelity FDA Review (NDA215430, ORIG 1, 2022)Axsome Therapeutics, Inc. · 2022
- Idorsia Ltd — Quviviq FDA Review (NDA214985, ORIG 1, 2022)Idorsia Ltd · 2022
- OSMOTICA PHARM US — Relexxii FDA Review (NDA216117, ORIG 1, 2022)OSMOTICA PHARM US · 2022
- NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2022)NOVEN PHARMS INC · 2022
- AbbVie Inc. — Vraylar FDA Review (NDA204370, SUPPL 9, 2022)AbbVie Inc. · 2022
- Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR public assessment report (EMEA/H/C/005406, 2022)Laboratorios Farmaceuticos Rovi, S.A. · 2022
- Idorsia Ltd — Quviviq EMA EPAR public assessment report (EMEA/H/C/005634, 2022)Idorsia Ltd · 2022
- Johnson & Johnson — Caplyta FDA Review (NDA209500, SUPPL 5, 2021)Johnson & Johnson · 2021
- Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, 2021)Supernus Pharmaceuticals, Inc. · 2021
- COMMAVE SUB — Azstarys FDA Review (NDA212994, ORIG 1, 2021)COMMAVE SUB · 2021
- Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021)Alkermes plc · 2021
- Johnson & Johnson — Caplyta FDA Review (NDA209500, SUPPL 6, 2021)Johnson & Johnson · 2021
- Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 2021)Tris Pharma · 2021
- Pharmanovia — Sunosi EMA EPAR variation assessment report (EMEA/H/C/004893, 2020)Pharmanovia · 2020
- Pharmanovia — Sunosi EMA EPAR public assessment report (EMEA/H/C/004893, 2020)Pharmanovia · 2020
- Takeda Pharmaceutical Company Limited — Trintellix FDA Review (NDA204447, SUPPL 20, 2020)Takeda Pharmaceutical Company Limited · 2020
- Neurocrine Biosciences, Inc. — Ingrezza FDA Review (NDA209241, SUPPL 16, 2020)Neurocrine Biosciences, Inc. · 2020
- Unknown MAH — Byannli (previously Paliperidone Janssen-Cilag International) EMA EPAR variation assessment report (EMEA/H/C/005486, 2020)Unknown MAH · 2020
- Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 2020)Vanda Pharmaceuticals Inc. · 2020
- Unknown MAH — Byannli (previously Paliperidone Janssen-Cilag International) EMA EPAR public assessment report (EMEA/H/C/005486, 2020)Unknown MAH · 2020
- Johnson & Johnson — Spravato EMA EPAR public assessment report (EMEA/H/C/004535, 2019)Johnson & Johnson · 2019
- Eisai Co., Ltd. — Dayvigo FDA Review (NDA212028, ORIG 1, 2019)Eisai Co., Ltd. · 2019
- Johnson & Johnson — Spravato EMA EPAR variation assessment report (EMEA/H/C/004535, 2019)Johnson & Johnson · 2019
- AbbVie Inc. — Vraylar FDA Review (NDA204370, SUPPL 6, 2019)AbbVie Inc. · 2019
- Axsome Therapeutics, Inc. — Sunosi FDA Review (NDA211230, ORIG 1, 2019)Axsome Therapeutics, Inc. · 2019
- Johnson & Johnson — Spravato FDA Review (NDA211243, ORIG 1, 2019)Johnson & Johnson · 2019
- HISAMITSU — Secuado FDA Review (NDA212268, ORIG 1, 2019)HISAMITSU · 2019
- Johnson & Johnson — Spravato EMA EPAR variation assessment report (EMEA/H/C/004535, 2019)Johnson & Johnson · 2019
- Takeda Pharmaceutical Company Limited — Trintellix FDA Review (NDA204447, SUPPL 17, 2018)Takeda Pharmaceutical Company Limited · 2018
- Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311, ORIG 1, 2018)Ironshore Pharmaceuticals · 2018
- ACADIA Pharmaceuticals Inc. — Nuplazid FDA Review (NDA210793, ORIG 1, 2018)ACADIA Pharmaceuticals Inc. · 2018
- Alkermes plc — Aristada FDA Review (NDA209830, ORIG 1, 2018)Alkermes plc · 2018
- Otsuka Holdings Co., Ltd. — Rxulti EMA EPAR public assessment report (EMEA/H/C/003841, 2018)Otsuka Holdings Co., Ltd. · 2018
- Otsuka Holdings Co., Ltd. — Rxulti EMA EPAR variation assessment report (EMEA/H/C/003841, 2018)Otsuka Holdings Co., Ltd. · 2018
- Otsuka Holdings Co., Ltd. — Rxulti EMA EPAR variation assessment report (EMEA/H/C/003841, 2018)Otsuka Holdings Co., Ltd. · 2018
- RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation assessment report (EMEA/H/C/004425, 2018)RAD Neurim Pharmaceuticals · 2018
- Alkermes plc — Aristada FDA Review (NDA209830, ORIG 1, 2018)Alkermes plc · 2018
- Alkermes plc — Aristada Initio FDA Review (NDA209830, ORIG 1, 2018)Alkermes plc · 2018
- RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation assessment report (EMEA/H/C/004425, 2018)RAD Neurim Pharmaceuticals · 2018
- Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311, ORIG 1, 2018)Ironshore Pharmaceuticals · 2018
- Otsuka Holdings Co., Ltd. — Rxulti EMA EPAR variation assessment report (EMEA/H/C/003841, 2018)Otsuka Holdings Co., Ltd. · 2018
- Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/C/004651, 2018)Camurus · 2018
- RAD Neurim Pharmaceuticals — Slenyto EMA EPAR public assessment report (EMEA/H/C/004425, 2018)RAD Neurim Pharmaceuticals · 2018
- BIOCORRX PHARMS — Lucemyra FDA Review (NDA209229, ORIG 1, 2018)BIOCORRX PHARMS · 2018
- NEOS THERAPS INC — Cotempla Xr-Odt FDA Review (NDA205489, ORIG 1, 2017)NEOS THERAPS INC · 2017
- Gedeon Richter Plc. — Reagila EMA EPAR public assessment report (EMEA/H/C/002770, 2017)Gedeon Richter Plc. · 2017
- Indivior PLC — Sublocade FDA Review (NDA209819, ORIG 1, 2017)Indivior PLC · 2017
- Gedeon Richter Plc. — Reagila EMA EPAR variation assessment report (EMEA/H/C/002770, 2017)Gedeon Richter Plc. · 2017
- Indivior PLC — Sublocade FDA Review (NDA209819, ORIG 1, 2017)Indivior PLC · 2017
- NEOS THERAPS INC — Cotempla Xr-Odt FDA Review (NDA205489, ORIG 1, 2017)NEOS THERAPS INC · 2017
- Accord S L U — Zubsolv EMA EPAR public assessment report (EMEA/H/C/004407, 2017)Accord S L U · 2017
- ACADIA Pharmaceuticals Inc. — Nuplazid FDA Review (NDA207318, ORIG 1, 2016)ACADIA Pharmaceuticals Inc. · 2016
- Vanda Pharmaceuticals Inc. — Hetlioz EMA EPAR public assessment report (EMEA/H/C/003870, 2015)Vanda Pharmaceuticals Inc. · 2015
- Otsuka Holdings Co., Ltd. — Rexulti FDA Review (NDA205422, ORIG 1, 2015)Otsuka Holdings Co., Ltd. · 2015
- Tris Pharma — Dyanavel Xr FDA Review (NDA208147, ORIG 1, 2015)Tris Pharma · 2015
- Johnson & Johnson — Trevicta (previously Paliperidone Janssen) EMA EPAR public assessment report (EMEA/H/C/004066, 2014)Johnson & Johnson · 2014
- Johnson & Johnson — Trevicta (previously Paliperidone Janssen) EMA EPAR variation assessment report (EMEA/H/C/004066, 2014)Johnson & Johnson · 2014
- Angelini Pharma — Latuda EMA EPAR variation assessment report (EMEA/H/C/002713, 2014)Angelini Pharma · 2014
- Angelini Pharma — Latuda EMA EPAR public assessment report (EMEA/H/C/002713, 2014)Angelini Pharma · 2014
- Eli Lilly and Company — Duloxetine Lilly EMA EPAR public assessment report (EMEA/H/C/004000, 2014)Eli Lilly and Company · 2014
- H. Lundbeck A/S — Selincro EMA EPAR public assessment report (EMEA/H/C/002583, 2013)H. Lundbeck A/S · 2013
- H. Lundbeck A/S — Brintellix EMA EPAR variation assessment report (EMEA/H/C/002717, 2013)H. Lundbeck A/S · 2013
- H. Lundbeck A/S — Brintellix EMA EPAR public assessment report (EMEA/H/C/002717, 2013)H. Lundbeck A/S · 2013
- Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public assessment report (EMEA/H/C/002755, 2013)Otsuka Holdings Co., Ltd. · 2013
- Ferrer Internacional — Adasuve EMA EPAR public assessment report (EMEA/H/C/002400, 2013)Ferrer Internacional · 2013
- Johnson & Johnson — Xeplion EMA EPAR public assessment report (EMEA/H/C/002105, 2011)Johnson & Johnson · 2011
- Organon & Co. — Sycrest EMA EPAR public assessment report (EMEA/H/C/001177, 2010)Organon & Co. · 2010