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

The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...

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 ...

The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...

By Julie Steenhuysen CHICAGO (Reuters) -Thousands of Americans campaigning for the Novavax COVID-19 booster got some good ...

The Trump administration is investing $500M in a project to develop "universal" vaccines that protect against multiple virus ...

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

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

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

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

As GSK weathers the storm of sinking vaccine sales and gears up for key launches in its specialty medicines sector, the ...