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FDA Approves Leucovorin for Rare Condition Amid Autism Claims

3/12/2026

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Summary

Story summary

The FDA approved leucovorin to treat cerebral folate deficiency (CFD-FOLR1), a rare condition affecting fewer than 50 people globally.
The U.S. President Donald Trump administration claimed leucovorin could benefit many children with autism.
FDA officials say there is insufficient evidence to support use for autism, despite a surge in prescriptions.
The approval rests on limited literature rather than extensive clinical trials.

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Story summary

The FDA approved leucovorin to treat cerebral folate deficiency (CFD-FOLR1), a rare condition affecting fewer than 50 people globally.
The U.S. President Donald Trump administration claimed leucovorin could benefit many children with autism.
FDA officials say there is insufficient evidence to support use for autism, despite a surge in prescriptions.
The approval rests on limited literature rather than extensive clinical trials.