Tolebrutinib, expected to soon be submitted for U.S. approval for nonrelapsing SPMS, was granted the FDA's breakthrough ...
Sanofi SNY announced that the FDA has granted a Breakthrough Therapy designation to its investigational oral BTK inhibitor, ...
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 ...
The Breakthrough Therapy designation is supported by data from the randomized, double-blind phase 3 HERCULES trial.
Sanofi’s investigational Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib has been granted breakthrough therapy ...
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of ...
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 ...
Paris: Sanofi has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ...
Paris: Sanofi has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ...
French drug major Sanofi (SNY) announced Friday that the U.S. Food and Drug Administration has granted Breakthrough Therapy ...
Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS) Tolebrutinib is the first and only brain-penetrant ...