A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

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

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

The FDA has approved Novavax’s protein-based COVID-19 vaccine, giving some Americans another option besides messenger RNA ...

In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid ...

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

In its Friday approval letter, the FDA didn’t explain the restrictions although they reflect skepticism about ...

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

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 advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.