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

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

Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review to the regulatory submission of tolebrutinib ...

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

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 ...

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

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

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 ...

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to ...

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 ...

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