Tag Archives: Approves

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers Print this page INDIANAPOLIS, May 8, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with… Read More »

FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer

FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer Print this page TOKYO and BOTHELL, Wash., Dec. 18, 2019 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev™ for the… Read More »

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 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 Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne

FDA Approves Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne Print this page FORT WORTH, Texas (October 4, 2019) Galderma, a global leader focused on meeting the world’s increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved Aklief (trifarotene) Cream, 0.005% for the topical treatment… Read More »

FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults

FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults Print this page London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Accrufer® (Feraccru® in… Read More »