sBLA, Dupixent and Regeneron

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.
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
Dupilumab Gets Priority Review for Bullous Pemphigoid
Dupilumab, an interleukin-4 receptor antagonist, is expected to decrease the type 2 inflammation seen in bullous pemphigoid.
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 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 sBLA accepted for FDA priority review for the targeted treatment of 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).
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
sBLA for Dupixent Accepted by FDA for Priority Review
The US Food and Drug Administration (FDA) has accepted for priority review Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP), a chronic, debilitating, and relapsing skin disease with underlying type-2 inflammation that typically occurs in an elderly population
pharmaphorum23h
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 ...
FiercePharma12d
Regeneron tangles with Sanofi over commercial transparency in long-running Dupixent collaboration
Immunology superstar Dupixent, which first brought Regeneron and Sanofi together in 2007, has entered its megablockbuster era ...
Healio1d
Rezpegaldesleukin gets FDA fast track designation for atopic dermatitis
The FDA has granted a fast track designation to rezpegaldesleukin for treating patients aged 12 years and older with moderate ...