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FDA Plans for Expedited Licensure Approval of GSK’s Autism Drug

FDA Plans for Expedited Licensure Approval of GSK’s Autism Drug

On Sept. 22, 2025, the U.S. Food and Drug Administration (FDA), in collaboration with the British pharmaceutical company GSK plc, announced plans to fast-track licensure of leucovorin calcium tablets. The drug, which GSK calls Wellcovorin, has long been used to treat anemia and counteract the effects of chemotherapy, The FDA will approve it for use […]

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