Tag Archives: Approves

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 »

FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell… Read More »

FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer

FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer London UK 22 April 2021 — GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics License Application. Jemperli is indicated for the treatment of adult… Read More »