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

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

As the FDA prepares for a busy Oncologic Drugs Advisory Committee next week, an agency insider told BioSpace that volunteers ...

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

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

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

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

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

“Americans have a very low uptake and a very low confidence of the COVID boosters right now.” He also said that the FDA is ...

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

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 ...