The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

An FDA panel meeting featured a heated dialogue over whether fluoride supplements could pose health risks to children. Here's ...

Studies leading up to the FDA approval found that people with hand eczema who used the cream were more likely to improve than ...

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II ...

Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in Silver Spring, Md.

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

An influx of illegal vapes that are appealing to children has been making its way into the U.S. from China, the head of the ...

On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications ...

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty ...