Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or ...

Vaccine maker Novavax is seeking to convert the 2022 emergency authorization of its Covid-19 vaccine into full approval. Yet ...

Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

Overall, the hazard ratio for in-hospital mortality at 28 days was 0.73 (95% confidence interval, 0.56 to 0.96) compared to ...

"You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA ...

Agency commissioner Dr. Marty Makary announced Tuesday that Dr. Vinay Prasad, a prominent COVID-19 vaccine critic, has been ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

While incidence of community-associated and healthcare-associated community-onset MRSA bacteremia declined during the ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

The head of the U.S. Food and Drug Administration (FDA) reiterated Tuesday that the agency is applying a more skeptical ...