A decision on tolebrutinib for treating MS is now set for Sept. 28, after the FDA granted priority review to its approval ...

If approved, SNY's tolebrutinib will be the first therapy to target smoldering neuroinflammation, a key driver of disability ...

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

Sanofi’s tolebrutinib has been accepted for priority review by the US Food and Drug Administration (FDA) to treat certain ...

Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple ...

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.

US FDA accepts for priority review Sanofi’s regulatory submission of tolebrutinib for patients with multiple sclerosis: Paris Wednesday, March 26, 2025, 09:00 Hrs [IST] The US F ...

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 ...