Tag Archives: Approves

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 »

FDA Approves Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP)

FDA Approves Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP) Print this page DUBLIN, Ireland, Aug. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved… Read More »