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

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

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.

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

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

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

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

Alzheimer’s disease remains one of medicine’s toughest challenges, affecting millions and costing trillions of dollars ...

The U.S. Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic ...

Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...

These changes will have knock-on impacts far beyond US borders, because regulators in many other countries expedite review of FDA-approved drugs. The FDA becomes involved before any new drug ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually determined after an approval in the U.S.