FDA accepts Biohaven's resubmitted application for spinocerebellar ataxia drug
Biohaven ($BHVN) said the FDA accepted its resubmitted application for Vyglxia, the proposed brand for troriluzole, to treat spinocerebellar ataxia. The submission includes additional supportive analyses and was deemed a complete response to the agency's earlier action letter. The FDA assigned a review goal in the first quarter of 2027. The agency also plans to convene its Peripheral and Central Nervous System Drugs Advisory Committee, although a meeting date has not been set. Acceptance restore
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