On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

"Most vaccines are not 100% effective, so you can see vaccine failures, but having vaccine failures doesn't mean the vaccine ...

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.

The U.S. Food and Drug Administration (FDA) is planning to require all new vaccines to undergo placebo-controlled trials before approval, multiple news outlets reported late Wednesday, citing the ...

In a release issued Monday, Novavax said it responded to an earlier FDA request to commit to providing more data on the vaccine if approved — a standard practice. Dr. Paul Offit, the director of ...