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Vanda receives FDA rejection, issues fiery response against ‘conclusory’ refusal

cafead

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Staff member
  • cafead   Sep 19, 2024 at 09:32: AM
via Vanda Pharmaceuticals has failed to persuade the FDA to approve its gastroparesis candidate on the strength of a phase 3 trial that missed its primary endpoint. The biotech came out swinging after the knock-back, accusing the agency of sending a complete response letter that generally disregarded the evidence.

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