The company recently hit significant roadblocks with its BTK inhibitor, but there are plenty of fish in the sea for the drug ...

Sanofi shares fell after an experimental treatment for multiple sclerosis was hit by a double setback, with results of a late-stage study missing a key goal and U.S. regulators signaling a decision on ...

PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to onset of 6-month composite confirmed disability progression compared to placebo ...

Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis Paris, December 24, 2025. The US Food and Drug Administration (FDA) has issued a ...

Sanofi said a U.S. regulatory decision on its tolebrutinib experimental treatment for a type of multiple sclerosis would be delayed again, and that a late-stage trial for a different form of the ...

In December 2025, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for Sanofi SA's (NASDAQ: SNY) new drug application of tolebrutinib to treat non-relapsing ...

Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the complete response letter, citing both efficacy and safety concerns—including a ...

Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to ...

Paris, December 24, 2025. The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary ...

Ongoing discussions with the FDA regarding nrSPMS application have indicated regulatory decision for tolebrutinib is anticipated to be delayed Paris, December 15, 2025. Sanofi anticipates that the ...