The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

Kennedy has been criticized for making false medical claims. He has also vowed to purge the U.S. Food and Drug Administration ...

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Shares in global vaccine makers and drugmakers fell on Friday after U.S. President-elect Donald Trump picked Robert F.

Since Politico reported on the potential selection Thursday afternoon, Pfizer and GSK shares are down about 5%, Sanofi's have ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.