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.

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 ...

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.

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

FDA’s Priority Tag to SNY’s Dupixent sBLA for Bullous Pemphigoid Sanofi and Regeneron announced that the FDA has accepted and granted priority review to an sBLA seeking approval of Dupixent ...

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Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA ...

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 ...