Sanofi ( (SNY) ) has issued an announcement. Sanofi announced that the FDA has granted Breakthrough Therapy designation to tolebrutinib for treating non-relapsing secondary progressive multiple ...
Tolebrutinib, expected to soon be submitted for U.S. approval for nonrelapsing SPMS, was granted the FDA's breakthrough ...
Sanofi’s investigational Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib has been granted breakthrough therapy ...
The Breakthrough Therapy designation is supported by data from the randomized, double-blind phase 3 HERCULES trial.
The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary ...
(IN BRIEF) The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS), following positive results ...
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of ...
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).
French drug major Sanofi (SNY) announced Friday that the U.S. Food and Drug Administration has granted Breakthrough Therapy ...
Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis Designation is based on positive results from the HERCULES study in adults with non-r ...
Tolebrutinib is a small molecule commercialized by Sanofi, with a leading Phase III program in Secondary Progressive Multiple Sclerosis (SPMS).