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 ...

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

The head of the FDA reiterated that the agency is applying a more skeptical approach to this year’s round of COVID-19 vaccine boosters.

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

He spent much of the pandemic criticizing the FDA’s and the Centers for Disease Control and Prevention’s response to the ...

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

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

The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.

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

The head of the U.S. Food and Drug Administration (FDA) reiterated Tuesday that the agency is applying a more skeptical approach to this year's round of COVID-19 vaccine boosters. Companies ...