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.

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

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.

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

Delgocitinib is a JAK inhibitor that blocks the activation of the JAK-STAT pathway which has been shown to play a key role in the pathophysiology of chronic inflammatory skin diseases.

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

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

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 ...

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

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

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