The FDA has rejected Sanofi's application seeking approval of tolebrutinib to treat certain forms of MS in its present form.

Exclusive: Scientists uncovered biological strands using artificial intelligence and hope discovery will revolutionise treatment ...

Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking ...

Sanofi (NASDAQ:SNY) is included among the 15 Global Dividend Stocks to Diversify Your Portfolio. Sanofi (NASDAQ:SNY) said on ...

Sanofi will not be pursuing approval of tolebrutinib for PPMS, and an FDA decision on the therapy in nonrelapsing SPMS will ...

Sanofi (SNY) announced on Wednesday that the U.S. FDA issued a complete response letter regarding its marketing application ...

That scuppered Sanofi's plans for filing tolebrutinib in PPMS, and the FDA has now slammed the brakes on its efforts to get ...

Lipoic acid offers no improvements in walking speed or other outcomes in patients with progressive multiple sclerosis ...

Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosisParis, December 24, 2025.

Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple sclerosis and is facing a delayed U.S. approval decision in another form of the ...

Findings showed the study met its primary endpoint demonstrating a reduction in disability accumulation with tolebrutinib compared with placebo. Tolebrutinib was found to delay disability progression ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS).