The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for tolebrutinib for the treatment of non-relapsing ...

Sanofi's oral BTK inhibitor tolebrutinib is heading towards an FDA decision in September as a potential treatment for multiple sclerosis (MS) after a priority review by the US regulator.

Sanofi said the GEMINI 1 and 2 trials of tolebrutinib in relapsing forms of MS are fully enrolled and should read out in time to meet its plan of filing for regulatory approval in the US in 2024.

Merck signed a licensing agreement for a heart disease drug with Jiangsu Hengrui Pharmaceuticals worth up to $2 billion.

Results of a post hoc analysis of 3 phase 3 trials of tolebrutinib suggest that PRLs are associated with an increased risk for disability accumulation in MS. Results of a post hoc analysis of 3 phase ...

These benefits were reported over a mean follow-up of two years, and… Treatment with the investigational BTK inhibitor tolebrutinib significantly delayed the onset of confirmed disability ...

The Phase III API-CAT trial found that extended anticoagulant therapy with reduced-dose Eliquis (apixaban) was noninferior to ...

Columnist Ahna Crum spent years trying to go it alone. Now she knows that freedom comes when she's flocking together with ...

Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) ...

The U.S. Food and Drug Administration approved Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult ...