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

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

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

Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as ...

An estimated 53 drugs would not enter the market in the next 30 years if the NIH is hit with a permanent 10% budget cut and the FDA experiences a nine-month drug review delay due to staffing cuts, the ...

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 ...

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 ...

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 ...

U.S. Food and Drug Administration (FDA) has assigned a target action date of June 23, 2025. December 23, ... Summary of the Pivotal Pooled TRUST-I and TRUST-II Data.

Michael Lewis on Heather Stone of the Food and Drug Administration. Heather Stone, a science policy analyst for the Food and Drug Administration's Center for Drug Evaluation and Research, at the ...