Zacks Investment Research on MSN4h
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 ...
pharmaphorum21h
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 ...
Pharmabiz6h
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 ...
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 ...
Applied Clinical Trials Online20h
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 ...
The Pharma Letter21h
FDA investigating tolebrutinib under priority review
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission by French pharma ...
Healio21d
Tolebrutinib particularly beneficial in patients with MS who have more MRI lesions
MRI paramagnetic rim lesions are associated with disability accumulation in multiple sclerosis. Tolebrutinib best mitigated disability risk in those with more paramagnetic rim lesions at baseline.
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 ...
pharmaphorum2d
Sanofi's tolebrutinib cuts MS progression by 31% in trial
Sanofi has bolstered the case for its oral BTK inhibitor tolebrutinib as a treatment for multiple sclerosis (MS), due to be filed for approval in the latter half of this year, with new data in a ...
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 ...
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 ...
Sanofi: 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 sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to ...