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

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 ...

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

D r. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

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

For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...

The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary ...

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner ...

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

Salmonella can cause serious and potentially fatal infections in young children, the frail or elderly, and others with ...