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.
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 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
FDA accepts Dupixent sBLA for priority review in bullous pemphigoid
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).
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
pharmaphorum2d
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 ...
FierceBiotech13d
Bristol Myers backs out of Dupixent fight, axing allergy asset despite phase 3 win
Cendakimab fell short of the bar. The antibody hits IL-13, one of the interleukins targeted by Regeneron and Sanofi’s ...
Sanofi: OpenAI's Research Agents Could Lead To Explosive Growth
Sanofi's deep partnership with OpenAI could be a huge differentiating factor. Check out why I rate SNY stock a buy.