Tag Archives: Approves

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) BOSTON, July 20, 2021 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in… Read More »

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute… Read More »

FDA Approves Blueprint Medicines’ Ayvakit (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis

First precision therapy that specifically targets the primary driver of the disease Durable clinical responses, including complete remissions, shown in patients with or without prior treatment Full approval supported by robust efficacy and safety data from two clinical trials — CAMBRIDGE, Mass., June 16, 2021 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that… Read More »

FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use

FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use WHIPPANY, N.J.–(BUSINESS WIRE) June 17, 2021– Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Astepro Allergy (Azelastine HCI .15%) as an over-the-counter (OTC) product for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay… Read More »