nrSPMS
FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025
FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA
Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review
Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review
Sanofi Prepares for Regulatory Submission of Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis
Tolebrutinib, BTK inhibitor, Multiple sclerosis, Non-relapsing secondary progressive multiple sclerosis (nrSPMS), Sanofi, HERCULES study, GEMINI 1 and 2 studies, Regulatory approval