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

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

It noted that, at the time, there were products "that were represented as jams containing fruit, but the products contained ...

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

The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...

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 ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

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

FDA Commissioner Dr. Marty Makary joins Morning Joe to address the agency’s controversial decision to keep Juul e-cigarettes ...

Solid Biosciences said federal regulators have granted its fast-track designation for the company's investigational gene therapy for the treatment of a heart rhythm condition.

By Sriparna Roy and Sneha S K (Reuters) -The U.S. Food and Drug Administration said on Monday it has appointed former biotech ...

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