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

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

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

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

FDA to release new guidance soon, clarifying its regulatory framework related to vaccines, particularly COVID-19 shots. Read ...

Millions of "long COVID" patients coping with debilitating "brain fog" and chronic fatigue, who are looking for answers to ...

The federal judge’s ruling has nothing to do with the merits of Kobach’s scientifically dubious argument that the vaccine isn’t as safe or effective as Pfizer advertised.

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

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

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

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