Tag Archives: Approves

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 Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma

FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma Print this page BRIDGEWATER, N.J., March 2, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least… Read More »

FDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

Print this page December 12, 2019 – Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF… Read More »

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease Print this page SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) —  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Oxbryta™ (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children… Read More »

FDA Approves Biorphen (phenylephrine hydrochloride) Ready-to-Use Injection for Hypotension During Anesthesia

FDA Approves Biorphen (phenylephrine hydrochloride) Ready-to-Use Injection for Hypotension During Anesthesia Print this page DEER PARK, Ill., Oct. 22, 2019 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that the U.S. Food and Drug Administration (FDA) has approved Biorphen, the first… Read More »