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

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

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

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

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 published more than 200 complete response letters, or decision letters, sent as ...

The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public health. The FDA was established when the Pure Food and Drugs Act was ...

The U.S. Food and Drug Agency is not really a singular agency. In practice, it operates more like five or more “FDAs” — each covering drugs, devices, food, cosmetics, or tobacco — combined ...