The FDA today announced a plan to publicly release complete response letters at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency ...

The Trump administration is preparing to roll out new dietary guidelines for Americans in early January, a move Food and Drug Administration (FDA) officials say will kick off a broader food policy ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

FDA leaders under President Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public ...

The Food and Drug Administration intends to get tougher on vaccine approvals, as top officials raised concerns about the risk of COVID vaccines for children. Speaking on Fox News Saturday morning, FDA ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

Matthew Herper covers medical innovation — both its promise and its perils. Changes to the ways in which the Food and Drug Administration plans to regulate vaccines represent a threat to effective and ...

Federal health officials added more ground cinnamon brands to its health alert after detecting elevated levels of lead in the product. The Food and Drug Administration (FDA) said in its latest update ...

WASHINGTON, Nov 10 (Reuters) - The U.S. Food and Drug Administration said on Monday it would remove the strictest "black box" warnings from hormone therapies used to treat menopause symptoms, a move ...

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...