The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for bullous pemphigoid by June 20, 2025.

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

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

EC approves MRK's Welireg for two indications. FDA grants priority review to SNY and REGN's Dupixent sBLA for bullous pemphigoid.

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 BP in the U.S.; FDA decision expected by June 20, 2025Priority ...

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).

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

Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for ...

The US Food and Drug Administration (FDA) has accepted for priority review Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid ...

The sBLA is supported by data from a pivotal trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more ...