Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Helen Branswell covers issues ...

WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions ...

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug ...

WASHINGTON, N.C. — The head of the Food and Drug Administration is questioning whether electronic cigarette maker Juul and its new partner Altria are following through on pledges to help reverse the ...

Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at ...

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...