The FDA is reviewing a new MS drug, tolebrutinib, which could be the first to tackle ongoing brain inflammation without relapses.

The FDA has accepted a priority review for tolebrutinib, a new drug targeting a type of multiple sclerosis (MS) that doesn't involve relapses. If approved, the drug would be the first brain-penetrant inhibitor of its kind, potentially offering a new treatment approach by addressing ongoing inflammation that contributes to MS disability. The FDA is expected to make a decision by September 28, 2025.