Nasdaq

SNY's Tolebrutinib Gets FDA Breakthrough Therapy Tag for nrSPMS

Sanofi SNY announced that the FDA has granted a Breakthrough Therapy designation to its investigational oral BTK inhibitor, tolebrutinib, for treating adults with non-relapsing secondary progressive ...
Becker's Hospital Review

U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM ...
Healio

FDA grants breakthrough therapy designation to tolebrutinib for MS

Please provide your email address to receive an email when new articles are posted on . The FDA granted breakthrough therapy designation to an oral, investigational, brain-penetrant and bioactive ...
Monthly Prescribing Reference

Tolebrutinib Gets Breakthrough Tx Status for Non-Relapsing Secondary Progressive MS

Treatment with tolebrutinib delayed the time to onset of 6-month CDP by 31% compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib ...