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

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

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

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 ...

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

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 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 updated its blood donation guidelines. Now, it goes off individual risk assessment ...

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

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

The deal hands AbbVie a drug that’s shown early promise in multiple myeloma and may be useful treating other cancers and ...