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

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German ...

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

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

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

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

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 ...

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

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...