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BioWorld - Friday, November 29, 2024
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» FDA refuses to review NDA for Biohaven’s ultra-rare disease treatment
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FDA refuses to review NDA for Biohaven’s ultra-rare disease treatment
July 27, 2023
By
Lee Landenberger
No Comments
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
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