FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
CAMBRIDGE, Mass.--(BUSINESS WIRE) - Jan. 23, 2020 -- Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Admini
FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
DUBLIN--(BUSINESS WIRE)--Jan. 21, 2020 -- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for the trea
FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia
MORRISTOWN, N.J., Jan. 29, 2020 /PRNewswire/ -- Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) i
FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia
PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted un
FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment
SAN DIEGO, CA – January 13, 2020 -- Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent,
FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherap
FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults
NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disord
FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine
DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Ubrelvy (ubrogepant) for t
FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
20 December 2019 -- AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu® (fam-trastuzumab deruxtecan-nx
FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients
December 23, 2019 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-hous
FDA Approves Conjupri (levamlodipine maleate) for the Treatment of Hypertension
Hong Kong, 20 December 2019 -- The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that Conjup
FDA Approves Ervebo (Ebola Zaire Vaccine, Live) for the Prevention of Disease Caused by Zaire Ebolavirus
KENILWORTH, N.J.--(BUSINESS WIRE) December 20, 2019 -- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approve
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