Sanofi Flags Delay in US FDA Decision on Multiple Sclerosis Drug Candidate

01:28 AM EST, 12/15/2025 (MT Newswires) -- Sanofi (SAN.PA) said Monday it expects a delay in the US Food and Drug Administration's review of tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis, or nrSPMS. The drugmaker anticipates the regulator's decision to be pushed back from the previously communicated target action date of Dec. 28, 2025, with updated guidance expected by the end of the first quarter of 2026. As such, Sanofi submitted an expanded access protocol for tolebrutinib in nrSPMS, allowing eligible patients to access the investigational therapy.