NDA News-CliniExpert

FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis

PRINCETON, N.J.--(BUSINESS WIRE) -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of a

FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease

March 06, 2020 -- The U.S. Food and Drug Administration today approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have

FDA Approves Durysta (bimatoprost implant) to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients

DUBLIN, March 5, 2020 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, today announced that the U.S. Food and Drug Adm

FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma

BRIDGEWATER, N.J., March 2, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for th

FDA Approves Advil Dual Action (ibuprofen and acetaminophen) as an Over-the-Counter Pain Treatment

WARREN, N.J., Feb. 28, 2020 /PRNewswire/ -- GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Advil Dual Action with Acetaminophen as an ove

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