FDA Rejects Biohaven's Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure on November 05, 2025 Ataxia, Spinocerebellar Biohaven clinical trial design Drug Approval external controls IL31RA gene In complete remission R&D rejection troriluzole United States Food and Drug Administration Vyglxia +
FDA Delays Decision on Biohaven's Troriluzole for Rare Disease, Plans Advisory Committee Review on May 15, 2025 Advisory Committees Ataxia Biohaven Deferred disease drug Extension Infrequent Neurodegenerative Disorders PDUFA Spinocerebellar troriluzole United States Food and Drug Administration +