Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...

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

The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine has created uncertainty across the vaccine industry, potentially affecting ...

Novavax’s COVID-19 vaccine could soon receive full approval from the United States Food and Drug Administration.

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

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.

"We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency," Novavax said in a statement Friday. "PMCs are not unusual with ...

CHICAGO, April 24 (Reuters) - Thousands of Americans campaigning for the Novavax (NVAX.O), opens new tab COVID-19 booster got some good news this week: the FDA signaled it might still win approval ...

Federal regulators are asking Novavax NVAX-5.66%decrease; red down pointing triangle to complete an additional randomized clinical trial on its Covid-19 vaccine after previously delaying approval ...

The U.S. FDA is asking Novavax (NASDAQ:NVAX) to conduct an additional randomized, controlled study of its COVID-19 vaccine before it will consider approving it. The prospect is a major setback for ...