The Food and Drug Administation is approving a generic drug for a very rare genetic disorder, but not for autism.

Food and Drug Administration Commissioner Marty Makary said in September he was changing leucovorin’s label because it could help “hundreds of thousands” of children with the neurological condition.

Washington — 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 ...

The Trump administration did an about-face Tuesday on an autism treatment Health Secretary Robert F. Kennedy Jr. had promoted with great fanfare.

The FDA approves leucovorin for a rare brain disorder while retreating from top officials’ earlier insistence that it could benefit many children with autism.

Six months ago, the federal government loudly proclaimed the likely benefits of an existing drug called leucovorin for treating autism. Now that proclamation has officially turned into a whimper. On ...

Leucovorin is now indicated for adult and pediatric patients with a confirmed variant in the folate receptor 1 gene, the agency said. This disorder affects fewer than one in 1 million people, with ...

By Ahmed Aboulenein and Julie Steenhuysen WASHINGTON, March 10 (Reuters) - The U.S. FDA on Tuesday approved leucovorin, a ...