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 Gets Appeals Court to Impose Tougher Kickback Standard
Regeneron Pharmaceuticals Inc. convinced the First Circuit to impose a higher causation standard in the government’s False Claims Act case alleging a drug kickback scheme, according to a Tuesday ...
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 ...
FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 ...
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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 ...