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 ...

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 U.S. Food and Drug Administration approved the use of Sanofi and Regeneron's blockbuster drug Dupixent for patients with ...

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and ...

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 FDA approved dupilumab (Dupixent) for chronic spontaneous urticaria (CSU) in patients 12 years and older, the first new ...

The FDA approved dupilumab for the treatment of patients 12 years and older with chronic spontaneous urticaria who remain ...

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...