Novavax's closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug ...

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

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

Novavax’s protein-based vaccine is only available under a pandemic-era emergency-use authorization, and formal approval from ...

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...

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.

Novavax said in a statement that it can confirm the delay in decision and that as of Tuesday, "we had responded to all of the FDA’s information requests and we believe that our BLA is ready for ...

Novavax's vaccine has been available since 2022 in the U.S. after the FDA granted its emergency use. "We look forward to ...

Investing.com -- Novavax (NASDAQ: NVAX) shares surged 13% following the biotechnology company’s optimism about its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).

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 ...

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