disease drug – Talk Bio

Actionable Insights Powered by AI

FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

3 weeks ago talkbio0Tagged Advisory Committees, Ataxia, Spinocerebellar, Biohaven, Deferred, disease drug, Extension, Infrequent, Neurodegenerative Disorders, PDUFA, Troriluzole, United States Food and Drug Administration

Biohaven; FDA delay; troriluzole; spinocerebellar ataxia (SCA); rare disease drug; PDUFA extension; advisory committee; neurodegenerative disease

Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges

6 months ago talkbio0Tagged Changing, disease drug, Govorestat, Leadership, regulatory, Rejection, United States Food and Drug Administration

Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges