Source: Reuters
“The U.S. FDA on Tuesday approved leucovorin, a decades-old generic drug, for use against an ultra-rare disorder called cerebral folate deficiency, but not for children with the much broader diagnosis of autism that it had promised last autumn to help, citing a lack of data. The approval for the rare genetic disorder, which causes autism-like symptoms, is a significant step back from the government’s September press conference when President Donald Trump and Health Secretary Robert F. Kennedy Jr. promoted the drug as a treatment for autism symptoms. … Leucovorin, also known as folinic acid, is a form of folate, an essential B vitamin, or B9. It is currently used in people undergoing chemotherapy but can be prescribed off-label for other uses.” [editor’s note: That last bit is important — a drug is either “approved” or not “approved” by FDA. “Approval” supposedly means that it is 1) safe, and 2) effective for some condition, but no separate “approval” is required for it to be prescribed for OTHER conditions. Vis a vis autism, the FDA is “not recommending” it, not “not approving” it – TLK] (03/10/26)