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 ...

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

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

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

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

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

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

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