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
US FDA accepts for priority review Sanofi & Regeneron’s Dupixent sBLA for the targeted treatment of bullous pemphigoid
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
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.
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 Sues Sanofi, Alleging Stonewalling in Dupixent Pact
According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug.
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of ...
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
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).
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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 ...
FiercePharma2d
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 ...