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
Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for Dupixent for treating bullous pemphigoid (BP), a chronic,
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.
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 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
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
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).
Sanofi: 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 pemphigoid If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision
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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 ...
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 ...