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.
GlobalData on MSN4d
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 ...
pharmaphorum3d
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 ...
PMLiVE3d
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 ...
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 ...
PharmiWeb4d
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).
The Pharma Letter4d
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 ...
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 ...
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 ...
Contract Pharma3d
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 ...
Morningstar4d
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 ...
Morningstar4d
Press Release: 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 expected by June 20, 2025 Priority review granted based on positive pivotal results ...