sBLA, Dupixent and 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.
SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag
The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for bullous pemphigoid by June 20, 2025.
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
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)
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 ...
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
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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 ...
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 ...
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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 ...
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Leerink group goes beyond conventional metrics to evaluate cost-effectiveness of key therapies
Over the last decade, as the Institute for Clinical and Economic Review (ICER) has estimated the cost-effectiveness of newly ...
Kymera Therapeutics: Plenty Of Potential, But A Long Way From The Finish Line
Kymera has $900 million in cash and no long-term debt, funding operations into mid-2027. Click here to read an analysis of ...