sBLA, Dupixent and FDA|FDA

FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues.
Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only
Dupilumab Gets Priority Review for Bullous Pemphigoid
Dupilumab, an interleukin-4 receptor antagonist, is expected to decrease the type 2 inflammation seen in bullous pemphigoid.
Regeneron, Sanofi Get Speedy FDA Review of Dupixent in Bullous Pemphigoid
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 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesions.
Sanofi and Regeneron’s Dupixent granted FDA priority review for bullous pemphigoid
Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA) to treat adults with bullous pemphigoid (BP).
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of 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, 2025Priority
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Can Dupixent plug treatment gap in bullous pemphigoid?
Bullous pemphigoid (BP), which has no FDA-approved targeted therapies, leads to reddening of the skin and the formation of ...
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Pharma Stock Roundup: EU Nod to MRK's Welireg, IONS' Q4 Results & More
This week, the European Commission granted approval to Merck’s MRK novel HIF-2α inhibitor, Welireg, for two indications. The ...
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Regeneron and Sanofi Announce FDA Priority Review for Dupixent® as Potential First Targeted Treatment for Bullous Pemphigoid
Dupixent may become the first targeted treatment for bullous pemphigoid in the U.S., pending FDA approval by June 2025. Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has ...