Tag Archives: Approves

FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade

FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade Print this page THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s… 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 Abrilada (adalimumab-afzb), a Biosimilar to Humira

FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira Print this page November 18, 2019 – Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing… Read More »

FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults

FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults Print this page TEL-AVIV, Israel and RALEIGH, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization… Read More »

FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions

FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions Print this page SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the… Read More »

FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta

FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta Print this page Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since… Read More »