But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

The FDA’s proposed amendments to 21 CFR Parts 600, 610 and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current ...

The FDA has posted a summary of Novo Nordisk (NVO) site inspections made over several dates in March of this year at the company’s Drug Substance Manufacturing Site in Kalundborg Sjalland 4400 ...

Just as the U.S. market has adapted to the increase in sales of approved GLP-1 drugs, leading to FDA-declared drug shortages and the availability of compounded versions, the litigation landscape ...

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...

Most publications on the effects of drugs on the teenage brain are written by scientists for scientists. Here is an overview of this research from a teenager's perspective.

AI-generated summary reviewed by our newsroom. Read our AI Policy. The FDA will stop annual COVID vaccines for many people under age 65 this fall. Eligibility will be tied to specific medical ...