Tag Archives: approves

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults Print this page PANGYO, South Korea and PARAMUS, N.J., Nov. 21, 2019 /PRNewswire/ — SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to market for central nervous system (CNS) disorders, and its U.S. subsidiary SK Life… 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 »

FDA Approves Ibsrela (tenapanor) for the Treatment of Irritable Bowel Syndrome with Constipation

Print this page FREMONT, Calif., Sept. 12, 2019 /PRNewswire/ — Ardelyx, Inc. today announced that the U.S. Food and Drug Administration has approved Ibsrela (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Ibsrela is a minimally-absorbed small molecule that acts locally in the… Read More »