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

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 ...

Novavax stock was climbing again on Monday after the company expressed new confidence in the eventual approval of its ...

The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services ...

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

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

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

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

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

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.