The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

The FDA has approved the Novavax COVID-19 vaccine, called Nuvaxovid, mainly for adults 65 or older, but people ages 12 to 64 with medical conditions that increase their risk of serious illness from ...

Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.

According to Makary and Prasad, the US’s adoption of a “one-size-fits-all” guidance for COVID-19 vaccination departs from ...

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...

(Reuters) -Novavax shares surged more than 17% before the bell on Monday, following the long-delayed approval of its COVID-19 ...

Novavax (NVAX) shares climbed more than 17% premarket on Monday after the long-delayed approval of its COVID-19 vaccine from ...

The policy has been outlined in an editorial in the New England Journal of Medicine (NEJM) by FDA Commissioner Marty Makary ...