The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...

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.

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 ...

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 ...

As the prospect of sector-specific tariffs under the second Trump administration continues to rattle drugmakers, a more ...

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

The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s ...

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

In an emailed statement to The Fly, Novavax (NVAX) said, “As we have previously stated, we believe that our Biologics License Application for ...

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 ...