The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns ...

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

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

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Usha Lee McFarling ...

Here are eight possible indicators of how health secretary Robert F. Kennedy Jr. may handle U.S. vaccine policy in coming ...

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

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

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

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

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 ...