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 ...

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

The FDA picked the LP.8.1 Covid strain for the fall vaccines, fueling concerns that the shots may be limited to only the most ...

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 agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

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

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.

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the ...