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 ...

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

Eli Lilly’s Ebglyss (lebrikizumab-lbkz) showed improvement in skin clearance and itch relief for most patients with ...

This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive ...

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

Regeneron released a strong financial report for Q3 and was the 15th of 16 in the last four years. Read why I upgrade REGN ...

EMA approves Dupixent to treat eosinophilic esophagitis in children as young as one year: Paris Thursday, November 7, 2024, 14:00 Hrs [IST] The European Medicines Agency has appro ...

Approval based on phase 3 data showing significantly more children aged one to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up ...

TARRYTOWN, N.Y. and PARIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent ...

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 ...

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to ...

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