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 ...

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

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the FDA means a product can stay on the market even after a health emergency ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the ...

Just last week, the US Food and Drug Administration delayed a decision on full approval of Novavax’s Covid-19 vaccine even though it was on track to be cleared, leaving many public health ...

On Wednesday, the company got word that the FDA would consider approving the vaccine, provided Novavax agrees to produce additional clinical data on the vaccine's efficacy following its approval.

Novavax's COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company said Wednesday. The update sent Novavax's stock up more than 21% in early ...

The Maryland-based company was asked by the Food and Drug Administration to show its vaccine is effective with another randomized study after appointees under Health Secretary Robert F.