The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

Dogs across the U.S. could soon get longer-lasting protection against pesky parasites thanks to a new treatment approved by ...

A growing disconnect remains between what generics are approved and what are actually accessible, GoodRx said.

The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.

The U.S. Food and Drug Administration updated its blood donation guidelines. Now, it goes off individual risk assessment ...