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 pediatric ...

Dupixent may become the first targeted treatment for bullous pemphigoid in the U.S., pending FDA approval by June 2025. Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a ...

FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade Safety results in all LIBERTY-CUPID Phase 3 trials were generally consistent with ...

Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration priority review of their application seeking expanded approval of their blockbuster anti-inflammatory drug Dupixent for ...

Paris and Tarrytown, N.Y. September 26, 2023. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® ...

Paris and Tarrytown, NY May 31, 2024. The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License ...

Please provide your email address to receive an email when new articles are posted on . If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the U.S. The ...

Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug Dupixent ...

Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision ...

The FDA has approved Sanofi and Regeneron’s Dupixent as a treatment for adults with bullous pemphigoid, a rare chronic autoimmune skin condition that causes severe itching, painful blisters and open ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is ...