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.

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

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.

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 ...

US FDA accepts for priority review Sanofi & Regeneron’s Dupixent sBLA for the targeted treatment of bullous pemphigoid: Paris Wednesday, February 19, 2025, 12:00 Hrs [IST] The U ...

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 ...