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 ...

Sanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another label expansion, this time for the rare autoimmune skin disorder bullous pemphigoid (BP). The US Food ...

Sanofi and Regeneron's Dupixent already boasts a long list of FDA-approved indications, and the latest to be reviewed could throw a lifeline to patients with a rare and debilitating autoimmune ...

If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the U.S. The submission was supported by a pivotal study which met its primary endpoint.

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent in adults with moderate-to-severe ...

The sBLA is supported by data from a pivotal trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more ...

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent (dupilumab) in adults ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for Dupixent to treat adults with bullous pemphigoid.

If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results ...

If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision expected by June 20, 2025 Priority review granted based on positive pivotal results ...

The sBLA is supported by data from a pivotal trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more Dupixent ...