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

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 ...

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

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

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

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

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

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

Looking at options history for Regeneron Pharmaceuticals REGN we detected 8 trades. If we consider the specifics of each ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...

Sanofi booked €26 million ($31 million) from the drug in the first three months of the year, with Regeneron recording $69 million in sales, although the partners both think that Libtayo as the ...

Regeneron and Alnylam are to research treatments for the chronic liver disease non-alcoholic steatohepatitis (NASH), under a new agreement. Alnylam specialises in treatments based around RNA ...