News

Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License ...
PharmExec2h
FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion
Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...
Regeneron to Reassess Strategy for Retinal Condition Treatment After FDA Rejects Dosing Plan
The FDA told Regeneron in a complete response letter that while it didn't identify any issues with the safety or efficacy of the drug in its approved indications and dosing regimens, the agency didn't ...
The Pharma Letter9h
Eylea HD injection 8mg sBLA accepted for FDA Priority Review
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech ...
Fierce Pharma7h
Fierce Pharma Asia—The latest on Trump's tariffs; Leqembi's EU approval; Kyowa Kirin's biologics plant
The Trump administration is expected to announce tariffs on pharmaceuticals "in the next month or two," an official said. | ...
Sanofi Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch ...
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...
Press Release: Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Approval based on phase 3 ...
pharmaphorum21h
Evidence builds behind Regeneron's deafness gene therapy
Ten out of 11 children with a form of congenital deafness who were treated with an experimental gene therapy developed by Regeneron have seen notable improvements in hearing, according to new data ...