Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.

Dr. Tracy Beth Høeg is leaving her role as head of the FDA division that regulates over-the-counter and prescription drugs, according to a Department of Health and Human Services official ...

WASHINGTON — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Trump’s administration is causing alarm across the agency, stoking ...

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 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 ...

Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to manufacturers, as well as online retailers, clinics, telehealth providers, and ...

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder.

The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other drug approvals ...