Tag Archives: approves

FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin

FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin Print this page Friday, June 28, 2019 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small… 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 »

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD) Print this page DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for… Read More »