The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

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

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug Blenrep as a combination treatment, ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...