The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

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 ...

Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another ...

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

Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as ...

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” ...

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

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