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

In 2024, Dupixent became the first of these medicines to be approved for COPD. This medicine may be an option for people who have COPD and also have high eosinophil levels. People with mild COPD ...

The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged one to ...

Regeneron announced Friday that the company won Food and Drug Administration approval for Dupixent in chronic obstructive ...

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections as an add-on therapy for adults with ...

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi have announced that the European Commission has granted approval for Dupixent (dupilumab) to be utilized in the treatment of ...

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 ...

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 ...

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