The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...

The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...

Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...

Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

Recently, the FDA announced the removal of certain compounded GLP1 ingredients from its drug shortage list. These ingredients ...

The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...

An urgent recall for hundreds of cases of frozen bread sold throughout the U.S. was issued after the FDA said "glass ...

The FDA has paused a quality control program for milk and dairy products. Food safety experts are concerned, but they say our ...

Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...

The testing of Grade A dairy products like pasteurized and raw milk, cheese, and yogurt are currently being paused by the FDA ...

A batch of the drug is under a limited voluntary recall after a shipping error exposed certain doses to improper temperatures.