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 ...

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

Paris and Tarrytown, NY, February 18, 2025. The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to ...

Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.

Sanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another label expansion, this time for the rare autoimmune skin disorder bullous pemphigoid (BP). The US Food ...

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 ...

This week, the European Commission granted approval to Merck’s MRK novel HIF-2α inhibitor, Welireg, for two indications. The ...

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application ...