Tag Archives: Approves

FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin

FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin Print this page INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE) December 14, 2018 –Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin®1 (trastuzumab) for the following indications: Adjuvant Breast… Read More »

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery Print this page BEDFORD, Mass.–(BUSINESS WIRE)–Dec. 3, 2018– Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration… Read More »

FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome

FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome Print this page November 28, 2018 — The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other… Read More »