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

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.

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 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 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 ...

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.

Moderna (MRNA) stock rises as the company's Spikevax COVID-19 vaccine gets FDA approval for kids 6 months-11 years at higher ...

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