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

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older against fleas and ticks.

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

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 ...

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

The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one ...

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 ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

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

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 ...