A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the ...

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

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

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

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

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

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

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