Investors riding a rare biotech recovery don’t need to jump off the train, but they should expect a bumpier ride. A mounting sense of chaos inside the agency—driven by interna

The Food and Drug Administration issued a Class II risk warning for two Caesar salad products possibly contaminated with plastic.

An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.

Twelve former U.S. FDA commissioners said on Wednesday they were deeply concerned about proposed changes to U.S. vaccine regulation by the agency's chief scientific officer and the details of his assertion that the COVID-19 vaccine killed 10 children.

FDA chief medical officer Vinay Prasad told reporters that the agency would be changing its vaccine approval process.

People with diabetes depend on glucose readings to manage their care. Incorrect low readings can lead to excessive carbohydrate intake or skipped or delayed insulin doses, Abbott said. Those decisions "may pose serious health risks, including potential injury or death," the company said.

The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research (CDER), continuing the rapid rise of a physician who rose to prominence during the pandemic.

Consumption or exposure to lead is unsafe for all ages, as it can cause neurological, developmental, and health issues.