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 ...
The Pharma Letter1d
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 ...
PharmiWeb1d
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).
Regeneron Pharmaceuticals, Inc.: 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, 2025 Priority Review granted based on positive pivotal results demonstrat ...
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 ...
manilatimes1d
Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook
Secured three additional regulatory approvals for world's first chikungunya vaccine, IXCHIQ ® (Canada, Europe, UK); filed adolescent label extension submissions; awarded new $41.3 million grant from ...
Astria Therapeutics: A High-Conviction Bet On HAE
Astria advances innovative therapies for hereditary angioedema and atopic dermatitis. Strong cash position supports pivotal ...