Biohaven has announced that their New Drug Application (NDA) resubmission for troriluzole (Vyglyxia) in spinocerebellar ataxia has been accepted for review by the FDA, and they have been granted an Advisory Committee Meeting. An NDA is the formal submission to the FDA requesting approval to market a new medicine in the US. Almost a year ago, in November 2025, their NDA for this medicine was rejected. The FDA are the medicine regulators in the US. This means that Biohaven is a step closer to trying to obtain approval of the drug in the US. Click here to read their announcement letter.
Biohaven’s New Drug Application for troriluzole in spinocerebellar ataxia has been accepted for review by the FDA
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