FDA keeps leucovorin for a rare condition, not autism
TL;DR
The FDA said leucovorin will be approved only for cerebral folate deficiency (CFD-FOLR1) and will not be expanded to autism, despite the Trump administration’s push. Regulators cited limited evidence for autism treatment and noted a retraction of a key study, narrowing the review to the rare CFD-FOLR1 condition and highlighting the gap between political claims and scientific proof for autism therapies.
- FDA contradicts Trump admin, declines to approve generic drug for autism Ars Technica
- FDA approves leucovorin for rare genetic condition, but not for autism CNN
- Trump admin backs off claims synthetic vitamin could help autism The Hill
- FDA approves new use of synthetic vitamin B9 — but not for autism symptoms NBC News
- FDA backs away from RFK Jr.’s claims about drug’s promise for autism patients Politico
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