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 ...

Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the ...

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

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

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 ...

The European Medicines Agency (EMA) approved Sanofi/Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) ...

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

US FDA accepts for review the resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria: Paris Monday, November 18, 2024, 11:00 Hrs [IST] The US Food and Drug Admin ...

Paris: Sanofi has announced that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic ...

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 ...