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

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

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

Dr. Marty Makary has been outspoken about vaccine mandates and other public health measures, so how does the Food and Drug ...

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

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

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

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

The rolls were sold at the retail level in Pennsylvania, California, Connecticut, Maryland, Delaware, and Ohio, according to ...

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

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

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