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

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

Resubmission of the supplemental biologics license application provided more data on improvement in hives and itching in ...

Patients who discontinued cancer immunotherapy because of immune-related adverse events (irAEs) often had durable benefits ...

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 ...

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

On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent ...

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales ...

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

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

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 ...