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 ...

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.

Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

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 ...

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 ...

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 ...

FDA is proposing the PM pathway largely in response to concerns from patient advocates and industry stakeholders that FDA’s existing product approval pathways lack sufficient flexibility for ...

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 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 ...