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 ...

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

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

This week, the European Commission granted approval to Merck’s MRK novel HIF-2α inhibitor, Welireg, for two indications. The ...

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 ...

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application ...

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.