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

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

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 ...

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

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

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

A regulatory submission is also under review in the European Union. If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary ...

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

The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to ...

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 ...

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 ...