There's little point in pouring hundreds of millions of dollars into creating a biosimilar if PBMs will refuse to cover it.

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

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

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

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

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

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

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.

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 ...

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 ...

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

CHICAGO (AP) — A son of notorious Mexican drug lord Joaquin “El Chapo” Guzman is expected to plead guilty in a sweeping U.S.