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.

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 ...

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

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 ...

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 ...

Priority review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious ...

Bullous pemphigoid (BP), which has no FDA-approved targeted therapies, leads to reddening of the skin and the formation of ...

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application ...

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 ...