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 ...
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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 ...
Bullous pemphigoid (BP), which has no FDA-approved targeted therapies, leads to reddening of the skin and the formation of ...
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 ...
Regeneron and Sanofi said an FDA green light would make Dupixent the first targeted medicine in the U.S. for bullous pemphigoid, a debilitating and relapsing skin disease with underlying type 2 ...
The following is a summary of “Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging ...
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 the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).
If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results demonstrat ...