FDA Drug Label - Search News

FDA approves leucovorin—but not for autism, even

FDA approves narrower use for drug floated for autism

The Food and Drug Administration on Tuesday approved using the drug leucovorin for a rare neurological condition — and not as a treatment for autism symptoms, as President Trump's health officials had suggested in September.

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FDA approves generic drug for a rare genetic condition, but not for autism

· 7h

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

18h

GSK wins FDA label expansion for RSV vaccine, Arexvy

GSK (GSK) stock is in focus as the U.S. FDA expands authorization for the company's Arexvy RSV vaccine to cover adults 18–49. Read more here.

11d

New Research Explores Gaps in Health Plan Implementation of FDA Label Revisions

Evidence suggests commercial health plans are more likely to delay specialty drug coverage decisions in response to FDA ...

Fierce Pharma

FDA answers Vanda's yearslong call for public hearing on unsuccessful jet lag approval bid

Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...

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