FDA Drug Approval Marks a First for a Disease — But It’s Not Autism
Frank Vinluan / medcitynews - Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.The post …
AI Summary: The FDA has granted traditional approval to leucovorin for cerebral folate deficiency, formalizing a decades‑old generic’s role in a rare metabolic disorder. The decision comes amid earlier agency notes that evidence for autism benefit was weak and debate over expanding use without fresh trial data — cue the policy hot takes.
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