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 ...

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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 ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and ...

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 ...

Sanofi and Regeneron have celebrated a pair of positive clinical trials in inflammatory skin disorders with blockbuster immunology therapy Dupixent that could both lead to new indications for the ...

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After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National ...

FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron ...

Credit: wisely via Shutterstock. The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent ...