FDA keeps leucovorin for a rare condition, not autism
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.