Zacks.com on MSN6d
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 ...
Multiple Sclerosis News Today6d
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 ...
pharmaphorum7d
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 ...
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 ...
PMLive6d
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 ...
MPR4d
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 ...
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Applied Clinical Trials Online7d
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 ...
PharmiWeb7d
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to ...
The Pharma Letter7d
FDA investigating tolebrutinib under priority review
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission by French pharma ...
Yahoo Finance7d
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 ...