FDA finds little evidence that a drug touted by Trump can help people with autism

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

FDA Doesn’t Endorse Leucovorin for Autism, OKs It for Rare Brain Disorder

The FDA declined to endorse leucovorin as a treatment for autism, but approved the drug to treat cerebral folate deficiency, ...

FDA finds little evidence that a generic drug could help many people with autism

The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration officials ...

FDA approves new use of synthetic vitamin B9 — but not for autism symptoms

The FDA announced a new approved use for the drug leucovorin, which Trump has touted as a treatment for autism. But the ...

FDA approves leucovorin for rare genetic condition, but not for autism

The prescription drug leucovorin is getting a label update, though it’s not what that the US Food and Drug Administration suggested might be coming during a White House briefing in September, when ...
Dermatology Advisor

New FDA Proposal Aims to Help Patients With Hard-to-Treat Diseases

The FDA proposed new guidelines for approving experimental therapies for rare diseases without large group studies.
Becker's Hospital Review

FDA looks to further ease biosimilar approvals

FDA looks further ease biosimilar approvals by allowing foreign clinical data and reducing pharmacokinetic study requirements to cut costs.
Hosted on MSN

AI at the FDA: help or hindrance?

The advent of AI at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices. In May, FDA commissioner Dr Martin Makary announced ...