FDA Accepts Roche’s Fenebrutinib NDA with Priority Review for Relapsing and Primary Progressive MS
The U.S. Food and Drug Administration has accepted Roche’s New Drug Application for fenebrutinib and granted the drug Priority Review designation for two forms of multiple sclerosis: relapsing multiple sclerosis and primary progressive multiple sclerosis. Roche announced the regulatory milestone on September 30, 2026. The PDUFA target action date, the deadline by which the FDA…
