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 ...

FDA Commissioner Marty Makary said Thursday that his agency is preparing to release a new regulatory framework within the ...

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 ...

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 ...

For years, U.S. vaccine experts have issued a universal recommendation for Covid vaccines. That could change soon.

Dr. Vinay Prasad, the FDA's new vaccine chief, has been accused of spreading misinformation about Covid vaccines.

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 says that a prominent medical contrarian and critic of the drug industry will head its ...