PARIS, France and TARRYTOWN, NY, USA I April 18, 2025 I The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of ...

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 ...

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 ...

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

Regeneron Pharmaceuticals and Sanofi won U.S. Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration has approved Dupixent for the treatment ...

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 ...

FDA accepts Regeneron's sBLA for Eylea HD in RVO with priority review; QUASAR data supports monthly dosing, target action date set for August 2025.

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.