The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the ...

In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...

One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they ...

The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.

The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax's COVID-19 vaccine, a source familiar with the matter told Reuters on Wednesday.

A top FDA official directly intervened in an agency review of Novavax’s Covid-19 vaccine, pausing the approval process to ask for more data on the shot, according to four people familiar with ...

Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.

Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. The agency is also ...

Novavax shifts to a partnership-focused strategy with a $500M Sanofi deal. Despite regulatory and competitive risks. See why ...

Vaccine maker Novavax's shares plunged nearly 20% at market close on Thursday, after Health and Human Services Secretary ...

Shares of Novavax (NVAX) are under pressure on Thursday following Robert F. Kennedy Jr.’s comments on the company’s COVID ...