Tag Archives: Approves

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 »

FDA Approves Rituxan (rituximab) for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) in Children

Print this page South San Francisco, CA — September 27, 2019 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in… Read More »

FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis

FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis Print this page NORTH CHICAGO, Ill., Aug. 16, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), a 15 mg, once-daily oral… Read More »