Worcester Telegram on MSNOpinion

Opinion/Guest column: Fastest route to FDA approval not the best

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and ...

No Broad Autism Approval for Leucovorin, Despite FDA Commissioner’s Prior Suggestions

The Food and Drug Administration on March 10 changed the approval for a version of the prescription drug leucovorin to include people with a very rare genetic condition. FDA Commissioner Dr. Marty ...

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 disorder, but not for autism after Trump's claims of drug's promise

In September, Trump and the FDA commissioner announced the drug was under review to benefit patients with autism. The FDA didn't find evidence of that.

FDA-approved cancer drug fedratinib reshapes how cell organelles communicate, providing new therapeutic avenues

Cells behave like cities and organelles carry out infrastructural roles: mitochondria are powerhouses, the endoplasmic ...

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 ...
Disability Scoop

FDA Widens Approval Of Drug Hyped For Autism

Months after Trump administration officials promoted a medication as a possible treatment for autism, the FDA is expanding ...
Hosted on MSN

White paper outlines FDA reforms to boost pharmaceutical innovation and expand access

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...

FDA Approves Leucovorin—But Not For Autism, Even After Trump Admin Officials Touted Drug Last Year

The drug was approved to treat cerebral folate deficiency, a rare genetic condition.

FDA Issues Landmark Biosimilar Guidance Incorporating Regulatory Reforms Advised by Professor Niazi: Further Cutting Development Costs by Up to 50%

The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)(1) , a sweeping guidance that codifies multiple regulatory ...
C&EN

FDA says it wants individualized medicines. Can we get there?

The drug was finally approved in September 2025 through the FDA’s accelerated approval pathway, based on improvement in knee extensor muscle strength, for adults and children with Barth syndrome who ...

FDA finds little evidence that drug touted by Trump helps with autism

WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back statements by President Donald Trump and other administration ...