Tag Archives: approval

Sanofi and Regeneron’s Dupixent scores 3rd FDA approval in sinusitis with nasal polyps

Dupixent won FDA approval Wednesday to treat adult patients with chronic rhinosinusitis with nasal polyps. (Sanofi) Sanofi and Regeneron’s Dupixent has been charging ahead since its initial approval in moderate-to-severe atopic dermatitis, later picking up a follow-up nod in moderate-to-severe asthma. Wednesday, the drug scored FDA approval for its third use: to treat adults with chronic… Read More »

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 »

Eversense Implantable Glucometer Gets FDA Approval as Alternative to Finger Tests

Senseonics, a company out of Germantown, Maryland, won FDA approval for its Eversense continuous glucose monitoring system. The system is intended to be used instead of traditional finger prick tests to make diabetes-related decisions. This is a giant step for the company, which has developed a technology that combines a tiny implant with a wearable… Read More »