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

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

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 warned in an interview with ABC News.

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Makary told ABC News the FDA recently sent a total of 800 letters to retailers and distributors of vapes, warning them about selling unauthorized products.

European pharma companies are breathing a sigh of relief after the Trump administration posed a 15% tariff, rather than 200% ...

With multiple clinical trials and approval applications in train, nuclear medicine superstar Telix Pharmaceuticals (ASX:TLX) is like one of those irritatingly brilliant all-round students.

Today's crop of last minute quarterly 'homework' isn't hiding too much of the nasty stuff synonomous with 'just-in-time' ...

The FDA named George Tidmarsh, who has led a number of biotech companies, to be its top drug regulator.

(Reuters) -The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and longtime Stanford University professor, as the director of the ...

Democratic state AGs are challenging the Trump administration’s restrictions on social services for immigrants in the country illegally.