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.

The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor tolebrutinib to treat multiple sclerosis (MS).

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 ...

Phase III SOUL trial shows daily oral semaglutide lowers the risk of major adverse cardiovascular events in patients with type 2 diabetes and atherosclerotic cardiovascular disease or chronic kidney ...

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

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

Reduction in spleen volume of ≥35% from baseline at week 24 was met in 65.9 and 35.2% of patients randomly assigned to pelabresib-ruxolitinib and placebo-ruxolitinib, respectively. HealthDay ...

Sanofi announced that The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple ...