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 ...

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

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

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.

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

The judge said a 2022 law that prevented pharmacists from contacting patients about the efficacy of ivermectin and ...

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

Senior leaders at the FDA began pushing Moderna and Pfizer to file for full, formal approval of their COVID vaccines for ...

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 ...