Multiple Sclerosis News Today20m
FDA grants priority review to application for tolebrutinib for MS
A decision on tolebrutinib for treating MS is now set for Sept. 28, after the FDA granted priority review to its approval ...
PMLive16m
Sanofi’s investigational MS treatment tolebrutinib granted FDA priority review
Sanofi’s tolebrutinib has been accepted for priority review by the US Food and Drug Administration (FDA) to treat certain cases of multiple sclerosis (MS).
Zacks Investment Research on MSN6h
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)
Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor ...
pharmaphorum23h
FDA starts review of Sanofi's MS hope tolebrutinib
The FDA review – which is due to be completed by 28th September – revolves around the results of the HERCULES trial which ...
Sanofi reports tolebrutinib submission accepted for FDA priority review
The U.S. Food and Drug Administration is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing ...
Applied Clinical Trials Online22h
Results of Phase III HERCULES, GEMINI 1 and 2 Trials Lead to FDA Priority Review for Tolebrutinib for Non-Relapsing Secondary Progressive MS
FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple ...
Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosisIf approved, tolebrutinib would be ...
Pharmabiz9h
US FDA accepts for priority review Sanofi’s regulatory submission of tolebrutinib for patients with multiple sclerosis
US FDA accepts for priority review Sanofi’s regulatory submission of tolebrutinib for patients with multiple sclerosis: Paris Wednesday, March 26, 2025, 09:00 Hrs [IST] The US F ...
The Pharma Letter23h
FDA investigating tolebrutinib under priority review
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission by French pharma ...
Medical Dialogues1d
Sanofi Tolebrutinib under USFDA priority review for multiple sclerosis
Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory ...
The American Journal of Managed Care11d
5 Ongoing Clinical Trials Evaluating Treatment for MS
National MS Education and Awareness Month is celebrated each year in the US in March, after having been launched in 2003 by ...
Healio21d
Tolebrutinib particularly beneficial in patients with MS who have more MRI lesions
Tolebrutinib best mitigated disability risk in those with more paramagnetic rim lesions at baseline. WEST PALM BEACH, Fla. — Tolebrutinib had the most protective effect against disability ...