Tag Archives: Approves

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 »

FDA Approves Gvoke (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia

FDA Approves Gvoke (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia Print this page CHICAGO–(BUSINESS WIRE)–Sep. 10, 2019– Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that it has received regulatory approval from the U.S.… Read More »

FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer

FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer Print this page WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 The FDA approval is based on the Phase III ARAMIS trial evaluating… Read More »