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 ...
Sanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another label expansion, this time for the ...
Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.
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 ...
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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 ...
Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA ...
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