Multiple Sclerosis News Today3d
Foralumab Phase 2a trial starts dosing patients at Yale MS Center
A Phase 2a trial testing foralumab nasal spray in people with nonactive SPMS has dosed the first patients enrolled at Yale MS ...
MPR3d
Tolebrutinib Under Review for Non-Relapsing Secondary Progressive MS
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for tolebrutinib for the treatment of non-relapsing ...
Multiple Sclerosis News Today5d
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 ...
PMLive5d
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 ...
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)
If approved, SNY's tolebrutinib will be the first therapy to target smoldering neuroinflammation, a key driver of disability ...
Pharmabiz6d
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 ...
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 Online6d
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 ...
Sanofi gets priority review for its multiple sclerosis treatment by FDA
Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review for the regulatory submission of tolebrutinib ...
pharmaphorum6d
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 ...
The Pharma Letter6d
FDA investigating tolebrutinib under priority review
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission by French pharma ...