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 ...

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

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

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

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

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

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 ...

Publix has had to manage several recalls involving both meat and non-meat products since the start of the year.

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 ...

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