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

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

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

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising urgent questions about the ...

Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.

The FDA may be making changes to how it handles COVID-19 booster shots. The agency’s top official says they’re taking a closer look at whether to approve boosters for this winter.

Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.

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

Without FDA approval, patients and vaccine experts say a group of people, including many patients with long COVID, will be left without a means of protecting themselves. "It's reassuring to see an ...