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

The agency is currently reviewing the study findings ...

The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis. Although the application was filed under the ...

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...

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 ...

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact ...

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 ...

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...