Zacks.com on MSN8d
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 ...
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 ...
Medical Dialogues9d
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 ...
Multiple Sclerosis News Today7d
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 ...
Yahoo Finance9d
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 ...
PharmiWeb8d
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 ...
Applied Clinical Trials Online8d
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 ...