FDA Approves Leucovorin, Retracts Autism Claims
Analysis based on 9 articles · First reported Mar 10, 2026 · Last updated Mar 10, 2026
The United States — Food and Drug Administration's approval of Folinic acid for a rare brain disorder, while retracting its efficacy for autism, creates uncertainty in the pharmaceutical market. This event highlights the impact of political statements on drug prescription rates and supply chains, as seen by the increased demand for Folinic acid and GSK plc's decision not to relaunch its version.
The United States — Food and Drug Administration approved Folinic acid for a rare brain disorder, but walked back earlier suggestions by Donald Trump and Marty Makary that the drug showed promise for autism. This retraction follows a White House news conference where the drug was touted for autism, leading to a 71% increase in Folinic acid prescriptions for children aged 5 to 17. Senior United States — Food and Drug Administration officials clarified that the review focused on evidence supporting its use only for patients with a rare genetic mutation affecting folate levels in the brain. The United States — Food and Drug Administration is now allowing imports of Folinic acid to boost supply, as GSK plc, the original manufacturer, does not plan to relaunch its version. Organizations like the Autism Science Foundation and the American Academy of Pediatrics do not recommend routine use of Folinic acid for autistic children, citing a lack of evidence and potential side effects.
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