But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval ... process for the Novavax vaccine, like all vaccines is based solely on ensuring safety and efficacy, ...

But full FDA approval would allow the vaccine to ... alternative to mRNA COVID-19 vaccines for the US,” Novavax added. The delay comes as the FDA is undergoing leadership changes.

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

Health secretary Robert F. Kennedy Jr. has expressed another unorthodox view on vaccines, declaring that single antigen ...

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

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

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

After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with ...

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

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

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...