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.

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional ...

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

Among other things, Makary breaks some news here by stating, for the first time, that there will be no significant ...

While Vaxart can proceed with its study, fellow COVID-19 vaccine developers GeoVax and Novavax continue to be hamstrung by ...

The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...

In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...

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

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

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

Federal regulators have requested that Novavax conduct an additional randomized clinical trial of its COVID-19 vaccine, a costly demand that could threaten the company’s ability to comply, The Wall ...

The Wall Street Journal reported that the Food and Drug Administration had missed the deadline for making a key decision regarding a COVID-19 vaccine from Novavax, days after the vaccine chief ...