This makes the new indication for Dupixent very important for Sanofi as it searches for a blockbuster to transform its fortunes. The FDA is set to make a decision on Dupixent’s new indication on ...

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 ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by ...

FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade Paris and Tarrytown, NY, November 15, 2024. The US Food and Drug ...

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 ...

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 ...

(REGN) announced Friday that the U.S. Food and Drug Administration has accepted for review the resubmission of the supplemental biologics license application or sBLA for Dupixent (dupilumab ...

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 ...