Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...

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

Pharmaceutical giant Novavax on Monday announced that the U.S. Food and Drug Administration (FDA) approved its COVID-19 ...

Key Takeaways Novavax received Food and Drug Administration approval for its new, protein-based COVID-19 vaccine.The shot, ...

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 ...

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 restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that ...

The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

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

The biotechnology company said the FDA approved the biologics license application for Nuvaxovid to prevent Covid-19 in adults ages 65 and up and individuals ages 12 through 64 who have at least one ...

Nuvaxovid is a recombinant protein-based COVID ... Jacobs, President and Chief Executive Officer, Novavax. Along with the approval, the FDA also requested Novavax conduct a phase 4 randomized ...

The U.S. Food and Drug Administration approved Novavax's Covid-19 vaccine with age restrictions after a six-week delay.