The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.

Novavax (NVAX) stock in focus as the U.S. FDA approves its COVID-19 vaccine Nuvaxovid for high-risk groups in the U.S. Read ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

Another Breakthrough Summit West in the books, and what an excellent event! We kicked off the day with former FDA head Robert ...

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking office, he’s promised to “investigate” children’s shots, canceled meetings ...

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

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

At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the situation ...

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

After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its ...