French drug major Sanofi (SNY) announced Friday that the U.S. Food and Drug Administration has granted Breakthrough Therapy ...

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of ...

The FDA bestows a Breakthrough Therapy designation to Sanofi's tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis.

Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosisDesignation is based on ...

Berger specialized in cancer long before joining Genentech, holding oncology global clinical development roles at Amgen and ...

The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary ...

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS).

The Breakthrough Therapy designation is supported by data from the randomized, double-blind phase 3 HERCULES trial.

Sanofi has bolstered the case for its oral BTK inhibitor tolebrutinib as a treatment for multiple sclerosis (MS), due to be filed for approval in the latter half of this year, with new data in a ...

Sanofi has said it plans to start discussions about filing its oral BTK inhibitor tolebrutinib for multiple sclerosis, even though the drug only achieved its primary objective in one of three ...

Public discussion and review panel voting is planned for June 2025. Tolebrutinib is an investigational Bruton’s tyrosine kinase (BTK) inhibitor being developed by Paris-based Sanofi for the treatment ...