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 ...

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

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

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

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

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

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

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

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

A Food and Drug Administration (FDA) expert panel has reignited a debate over whether hormone therapy should be used to treat ...

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