The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines.

Commissioner Marty Makary on Monday denied recent reports suggesting plans for his agency to add a black box warning to COVID ...

Traws Pharma reports interim Phase 2 data showing ratutrelvir performed comparably to Paxlovid in mild-to-moderate COVID-19 ...

I wanted the ultimate movie-night experience, so I decided to turn my entire house into a full-on movie theater. We installed ...

Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and ...