Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…