NDA News-CliniExpert

FDA Approves Nurtec ODT (rimegepant) for the Acute Treatment of Migraine in Adults

NEW HAVEN, Conn., Feb. 27, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that the U.S. Food and Drug Administration (FDA) has approved Nurtec ODT (rime

FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol

ANN ARBOR, Mich., Feb. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced today that the U.S. Food and Drug Administration (FDA) approved Nexletol™ (bempedoic acid) tablet, an oral, once-da

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,