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 ...
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 ...
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 ...
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only ...
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application ...
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