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 ...

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

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 ...

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

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

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’s new atopic dermatitis treatment Dupixent has gained EU approval, setting it up for a launch across key European markets. Dupixent (dupilumab) is tipped to be the market leader among a ...

Sanofi is already a major player in the ASD market with its big-selling IL-4 and IL-13 inhibitor Dupixent (dupilumab), and the company has previously highlighted amlitelimab as one of a dozen ...

A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to treat ...