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 ...

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

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

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

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

NICE has said “no” to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in first draft guidance, citing uncertainties with evidence.

18 months after saying "no" to regular NHS funding for Sanofi and Regeneron's Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed the drug. The final appraisal ...

The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...

and Sanofi will present positive data from the Phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent ® (dupilumab) in biologic-naïve patients with uncontrolled 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 ...

Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status ...