Tag Archives: Approves

FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A

FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A Print this page Bagsværd, Denmark, 19 February 2019 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of adults and children with hemophilia A. Esperoct is the brand name for… Read More »

FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause

Print this page BLAINVILLE, QC, January 29, 2019 – Duchesnay Inc., a pharmaceutical company specializing in women’s health, announced today that the FDA has approved its supplemental New Drug Application (sNDA) seeking to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena… Read More »

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease Print this page ARDSLEY, N.Y.–(BUSINESS WIRE) December 21, 2018 –Acorda Therapeutics, Inc. 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… Read More »