Zacks.com on MSN5d
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib
If approved, SNY's tolebrutinib will be the first therapy to target smoldering neuroinflammation, a key driver of disability ...
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 ...
Medical Dialogues6d
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 ...
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 ...
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 ...
Yahoo Finance5d
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 ...
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 ...
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 ...