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 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).

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 ...

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 ...

Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS) Tolebrutinib is the first and only brain-penetrant BTK ...

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

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 ...