Dupixent, Regeneron and sBLA

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.
Regeneron, Sanofi announce Dupixent sBLA accepted for priority review by FDA
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for
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.
Dupilumab Under FDA Priority Review for Bullous Pemphigoid
Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.
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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Sanofi nears selling 50 percent controlling stake in Opella to CD&R
Paris: Sanofi and CD&R have announced that they have signed the share purchase agreement in relation to the sale of a 50 ...
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Regeneron and Sanofi Announce FDA Priority Review for Dupixent® as Potential First Targeted Treatment for Bullous Pemphigoid
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a supplemental Biologics License Application for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP), a ...
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Rx Rundown: Moderna, Sanofi, GSK and more
Millie, a modern maternity clinic, secured $12 million in Series A funding led by existing investors RH Capital, TMV, ...
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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 ...
Why Regeneron's Price May Soon Break Out
Regeneron Pharmaceuticals' fourth quarter results beat my and Wall Street analysts' expectations. See why REGN stock is a top ...