Multiple Sclerosis News Today3d
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 ...
MPR1d
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 ...
PMLive4d
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 ...
pharmaphorum5d
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 ...
Zacks Investment Research on MSN5d
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib
Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor ...
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 Online5d
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 ...
Medical Dialogues5d
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 ...
Yahoo Finance4d
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 tolebrutinib to treat non-relapsing secondary progressive multiple ...
Yahoo Finance5d
Press Release: 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 both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation ...