Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

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

Novavax on Wednesday said the U.S. Food and Drug Administration has asked the company to commit to produce more data on its ...

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 ...

Novavax's COVID-19 vaccine showed fewer side effects than Pfizer's in a Utah study as FDA seeks more data before full ...

The FDA is considering the approval of the Novavax COVID-19 booster after delays amid controversy over its non-mRNA design.

Healthcare & Pharmaceuticalscategory As FDA delays Novavax' COVID vaccine approval, patients fight back 12:45 PM UTC · Updated ago Healthcare & Pharmaceuticalscategory Drugmakers brace for Trump ...

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a ...

A top FDA official directly intervened in an agency review of Novavax’s Covid-19 vaccine, pausing the approval process to ask for more data on the shot, according to four people familiar with ...

Kennedy Jr., and that the deputy commissioner at the FDA intervened in the Novavax decision, are fueling concerns about the anti-vaccine beliefs of RFK Jr. and the potential impact to the industry.