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

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

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

The head of the U.S. Food and Drug Administration on Tuesday reportedly raised doubts about the need for COVID booster shots ...

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

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 ...

Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter ...

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

The Food and Drug Administration (FDA) has tapped Vinay Prasad, a prominent critic of federal COVID-19 policies and a ...

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