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

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

The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved ... Further boosting the pipeline, ...

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 ...

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

Sanofi SNY and partner Regeneron REGN announced that the FDA has approved their blockbuster drug, Dupixent, for its sixth indication — chronic obstructive pulmonary disease (COPD ...

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

The European Medicines Agency (EMA) approved Sanofi/Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one. The approval extends the use of Dupixent ...

This expansion positions Dupixent as the first targeted therapy ... Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc ...