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

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

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging ...

Merck's animal health division received Food and Drug Administration approval for its once-yearly injectable flea-and-tick treatment for dogs. Merck Animal Health said Thursday it expects its Bravecto ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

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

Lenacapavir is available in both oral tablet form and as subcutaneous injections. It is available as oral tablets and ...

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

Arcus Biosciences announced that the Food and Drug Administration has granted its pancreatic cancer treatment, quemliclustat, with an orphan drug designation. The company said it expects its ongoing ...

Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria said on Wednesday they had finalized plans to ...