FDA Approves Leucovorin for Rare Conditions, Declines Autism Treatment Claims
The FDA has recently approved leucovorin for specific rare genetic disorders, including cerebral folate transport deficiency, but has explicitly stated that there is insufficient evidence to support its use as a treatment for autism. Despite significant promotion of the drug by the Trump administration, which suggested it could assist individuals with autism, the FDA has stepped back from these claims, affirming that the drug lacks clinical endorsement for such purposes. Parents and advocates who had hoped for a breakthrough are left disappointed as the FDA continues to emphasize the need for more robust clinical data to validate any potential benefits of leucovorin for autism.
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