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 ...

Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitisApproval based on phase 3 data showing ...

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

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 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 ...

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

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

“Eosinophilic esophagitis presents a unique challenge ... and a principal inventor of Dupixent. “This approval will bring the proven efficacy and demonstrated safety profile of Dupixent ...

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 ...

Dupixent is also approved in this young age group in the U.S. and Canada. “Young children with eosinophilic esophagitis are at the beginning of their life-long journey with a disease that ...