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.

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

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 ...

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

for Dupixent ® (dupilumab) to treat adults with bullous pemphigoid (BP). The sBLA is supported by data from a pivotal trial evaluating the efficacy and safety of Dupixent in 106 adults with ...

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

Paris: Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to ...

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

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