Tag Archives: Approves

FDA Approves Epclusa (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection

Print this page FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at… Read More »

FDA Approves Ofev (Nintedanib), For The Treatment of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype

FDA Approves Ofev (Nintedanib), For The Treatment of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Print this page March 09, 2020 — The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the… Read More »

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch Print this page 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 and Drug Administration (FDA) has approved Twirla (levonorgestrel and ethinyl estradiol) transdermal system. INDICATION AND… Read More »

FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease

Print this page PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults… Read More »

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED) Print this page 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 treatment of Thyroid Eye Disease (TED). Tepezza is the first and only FDA-approved medicine for… Read More »