FDA Withdraws GSK’s Approval of Drug Touted as Autism Treatment

April 9, 2026, 7:31 PM UTC

US regulators have withdrawn their approval of a GSK Plc drug that the Trump administration had promoted as a treatment for autism, adding another twist to the unusual story of a decades-old drug.

The Food and Drug Administration is pulling its approval of Wellcovorin, a branded version of leucovorin from GSK Plc, according to a post Thursday in the Federal Register. GSK had requested that the approval be withdrawn, the post said.

The FDA first approved leucovorin decades ago and it’s been used to blunt the side effects of chemotherapy for some cancer patients. In September, Trump administration officials endorsed ...

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