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FDA approves drug that Trump due to suggest as autism treatment
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FDA approves drug that Trump due to suggest as autism treatment
Sep 23, 2025 1:20 PM

(In Sept 22 story, corrects paragraph one to folinic acid from

folic acid)

Sept 22 (Reuters) - The U.S. Food and Drug

Administration announced approval of leucovorin, or folinic

acid, that U.S. President Donald Trump was slated to suggest as

a treatment for autism symptoms at a White House event on

Monday.

The FDA published a notice in the Federal Register.

GSK previously manufactured leucovorin and sold it

under the name Wellcovorin. The company withdrew the drug from

the market, but not for reasons of safety or effectiveness.

The Federal Register notice cited "patient-level data on

over 40 patients, including both adults and pediatric patients"

to support the finding that the drug can improve symptoms from

cerebral folate deficiency (CFD).

According to the Federal Register entry, CFD has been

reported in patients with neuropsychiatric symptoms, including

autistic features.

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