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

Italian tyre maker Pirelli is in a risky situation after its Chinese leading shareholder Sinochem rejected a proposal by the ...

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

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

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

This vaccine did previously have emergency approval by the FDA for use but can now be marketed in the U.S. for use, the ...

The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

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

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

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

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.