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

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

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

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 ...

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 ...

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 ...

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

2 Top Growth Stocks to Buy on the Dip was originally published by The Motley Fool ...

This expansion positions Dupixent as the first targeted therapy for COPD ... Further boosting the pipeline, mid-stage drugs ...

Once again, Dupixent finished in second place with an impressions SOV of 5.40% and 2.8 billion impressions. Notably, the ...

The companies did not provide detailed data for Tezspire, however, and William Blair’s Matt Phipps said in a note he does not ...