FDA Delays Approval Decision for Biohaven Rare Disease Drug

FDA delays approval decision for Biohaven rare disease drug

Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an outside group of advisers to evaluate it as well.

Biohaven stock sinks on three-month delay for neuro drug's FDA approval decision

Biohaven said late Wednesday that the FDA would be delaying the PDUFA date for its neurodegenerative disease therapy troriluzole and will also require an advisory committee meeting to review the drug. The agency’s move came ...

First-Ever Treatment for Fatal Ataxia Disease Faces Critical FDA Decision: What's Next for Biohaven

FDA extends review of troriluzole, showing 70% disease slowdown in rare ataxia. Advisory committee meeting planned. Learn what this means for patients.