NDA News-CliniExpert

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch

PRINCETON, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food an

FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE) February 10, 2020 -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has received final approval from the U.S. Food

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved

FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy

BRISBANE, Calif.--(BUSINESS WIRE)--Jan. 31, 2020 -- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening fo

FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in Adults

RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 27, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended rele

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