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 framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

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

President Donald Trump's tax cut and spending bill faces a critical stress test on Wednesday as Republicans in the U.S. House ...

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

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

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

Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID ...

The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to ...