SAN DIEGO -- Investigational tolebrutinib slowed disability progression in people with non-relapsing secondary progressive multiple sclerosis (SPMS), the phase III HERCULES trial showed. The Bruton's ...

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

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).

A Cleveland Clinic-led clinical trial of tolebrutinib, an investigational oral Bruton's tyrosine kinase inhibitor, a group of drugs originally developed to treat lymphomas and related blood disorders, ...

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 ...

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 ...

Heidi Crayton, MD, and Maria Lopes, MD, discuss the impact of multiple sclerosis on patients, families, and caregivers, differentiate relapsing forms (relapsing-remitting and primary progressive) from ...

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 ...

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 provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis Ongoing discussions with the FDA regarding nrSPMS application have indicated ...