Specialty Pharma Journal Specialty, Precision & Technology
DUBLIN–(BUSINESS WIRE)–Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for RAVICTI® (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder (UCD). …
Tag Archives: fda
December, 2018
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26 December
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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26 December
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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26 December
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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21 December
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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21 December
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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20 December
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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20 December
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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20 December
FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma
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 approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the …
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20 December
AstraZeneca’s Lynparza Granted FDA Approval for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial …