The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic ...

The FDA decision is expected by April 18, 2025. If approved, Dupixent would be the first targeted therapy for CSU in a decade. The sBLA for Dupixent (dupilumab) is to treat adults and pediatric ...

The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved lung function by 160 mL at 52 weeks. Approximately 44 million COPD cases were recorded in 2023 in the 7MM ...

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 ...

Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch. The companies said an ...

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 ...

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 one ...

AbbVie is reaching for the Sky(rizi) as it spent a staggering $51.5 million on TV drug ads for its immunology blockbuster in October. | AbbVie is reaching for the Sky(rizi) as it spent a staggering ...

TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ:SNY) have reported positive outcomes from a Phase 3 trial of Dupixent (dupilumab) in patients 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 ...