“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.

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

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

Novavax is working with the FDA to meet additional requirements and hopes to secure full approval as soon as possible.

Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...

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-only vaccine is once again expected to move from emergency approval to full approval status following a pause.

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...