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

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

Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor ...

The FDA review – which is due to be completed by 28th September – revolves around the results of the HERCULES trial which ...

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosisIf approved, tolebrutinib would be ...

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’s tolebrutinib has been accepted for priority review by the US Food and Drug Administration (FDA) to treat certain cases of multiple sclerosis (MS).

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple ...

The U.S. Food and Drug Administration is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing ...

Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory ...

If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation ...

PARIS, France I March 25, 2025 I The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to ...