Has the tolebrutinib road ended?
The fast track may have turned into a dead end for tolebrutinib, Sanofi’s Bruton tyrosine kinase (BTK) inhibitor for multiple sclerosis (MS) treatment. The US Food and Drug Administration (FDA) has denied approval of the experimental treatment in its current form, saying “a favorable benefit-fisk profile could not be established for any patient population.” In a Complete Response Letter (CRL), released with redactions on January 6, 2026, the agency said…Continue Reading