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FDA Approves Vaxelis, Sanofi and Merck’s Pediatric Hexavalent Combination Vaccine

PARIS and KENILWORTH, N.J. – December 26, 2018 – The U.S. Food and Drug Administration has approved VAXELIS(TM) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th …

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FDA Approves Acorda’s Inbrija for Intermittent Treatment of OFF Episodes in Patients with Parkinson’s Disease

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration approved INBRIJA™ for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low …

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FDA Approves First and Only Digital Inhaler with Built-in Sensors – ProAir Digihaler Inhalation Powder

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to …

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Alexion Receives Early FDA Approval for Ultomiris in Adults with Paroxysmal Nocturnal Hemoglobinuria

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved ULTOMIRIS™ (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating ultra-rare blood disorder characterized by complement-mediated destruction …

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FDA Approves Stemline’s Elzonris, the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm, a Rare Blood Disease

The U.S. Food and Drug Administration today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. “Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care …

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Janssen Submits Application for FDA Approval of Stelara for Treatment of Moderately to Severely Active Ulcerative Colitis

HORSHAM, Pa., Dec. 20, 2018  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis. STELARA …

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FDA Extends Action Date for Merck’s sBLA for Keytruda as Monotherapy for First-Line Treatment of Advanced or Metastatic NSCLC in Tumors with PD-L1 Expression

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced …

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Gritstone Oncology Announces FDA Fast Track Designation for GRANITE-001 for the Treatment of Colorectal Cancer

EMERYVILLE, Calif., Dec. 20, 2018 (GLOBE NEWSWIRE) — Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GRANITE-001 for the treatment of …

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Sarepta Completes Submission of NDA Seeking Approval of Golodirsen in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53

CAMBRIDGE, Mass., Dec. 20, 2018 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, announced today that it has completed the submission of its rolling New Drug Application (NDA) seeking accelerated approval for golodirsen (SRP-4053), a phosphordiamidate morpholino oligimer engineered to treat those …

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AbbVie Submits Applications to the FDA and EMA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for …

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