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

FDA Approves Durysta (bimatoprost implant) to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients Print this page 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 Administration (FDA) has… Read More »

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

FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease Print this page 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 undergone the surgery but still have the disease. Cushing’s disease is a… 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 Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta

FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta Print this page 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 and Drug Administration (“FDA”) for its novel product, Pemfexy (pemetrexed for injection),… Read More »