As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults with bullous pemphigoid.

Bullous pemphigoid (BP), which has no FDA-approved targeted therapies, leads to reddening of the skin and the formation of ...

Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.

Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only ...

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 ...

A Prescription Drug User Fee Act target date of June 20, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics ...