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

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

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

Several food items sold in vending machines throughout Ohio, northern Kentucky, and eastern Indiana are being recalled due to ...

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

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

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

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 ...

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

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

The recommended age to start screening for colorectal cancer was lowered in 2021 from 50 to 45 for people of average risk.

News about Food and Drug Administration, including commentary and archival articles published in The New York Times.