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

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by ...

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

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

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

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

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

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

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...

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