Sanofi has bolstered the case for its oral BTK inhibitor tolebrutinib as a treatment for multiple sclerosis (MS), due to be filed for approval in the latter half of this year, with new data in a ...

Sanofi's oral BTK inhibitor tolebrutinib is heading towards an FDA decision in September as a potential treatment for multiple sclerosis (MS) after a priority review by the US regulator.

Immunic’s lead oral small molecule has failed to hit the primary endpoint of a phase 2 trial in patients with progressive ...

According to CEO Daniel Vitt, clinical and disability-related outcomes are more relevant than brain volume change for drug ...

In December 2024, the drug tolebrutinib received the FDA’s “breakthrough therapy” designation for use in non-remitting SPMS. No DMTs have yet been approved to treat SPMS in a non-remitting ...

Sanofi’s tolebrutinib, an investigational oral Bruton’s tyrosine kinase inhibitor, demonstrated a 31% delay in the onset of six-month confirmed disability progression in patients with non-active, ...

Tolebrutinib did not show superiority over Aubagio (teriflunomide) in reducing relapse rates or MRI-detected inflammatory activity in relapsing multiple sclerosis, but early signals suggest it may ...

The likelihood was lower when considering therapies that are highly effective at controlling… Sanofi‘s oral BTK inhibitor tolebrutinib significantly delayed the onset of six-month confirmed ...

New Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organisation (CDSCO), has ...