FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

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

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 ...

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

A former Pfizer scientist said the timing of the 2020 vaccine results “wasn’t a coincidence,” according to allegations ...

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 ...

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 ...

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 ...