The U.S. Food and Drug Administration is warning that certain half-shell oysters that are frozen and raw harvested in South ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud.

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should ...

Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.

It began in 2020 with a coordinated push to generate public backlash to lockdowns. The ultimate aim was restoring normalcy, ...

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials.

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 ...

US Food and Drug Administration officials are changing the agency's standards for updated COVID-19 booster shots with focus ...

FDA changes COVID-19 vaccine approval policy, major trials now required for widespread use. Higher risk individuals still ...

The FDA has granted full approval for Novavax's COVID-19 vaccine, but with restrictions. Discover the details now.

According to Makary and Prasad, the US’s adoption of a “one-size-fits-all” guidance for COVID-19 vaccination departs from ...