Tag Archives: approval

Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

Print this page BEDFORD, Mass.–(BUSINESS WIRE)–Jun. 21, 2019– Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Dextenza to include the treatment… Read More »

FDA Grants Genentech’s Polivy (polatuzumab vedotin-piiq) Accelerated Approval for Adults With Previously Treated Aggressive Lymphoma

Print this page South San Francisco, CA — June 10, 2019 — Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R)… Read More »

Scott Gottlieb lauded for tough stance on tobacco and vaping, approval of new drugs at FDA

Following the surprise announcement of his pending resignation, Scott Gottlieb, the soon-to-be former commissioner of the FDA, is being lauded for his championing of public health, his stance on e-cigarettes and vaping and his service as a physician. Dr. Gottlieb made the announcement yesterday, saying it was hard for him to leave the position but… Read More »