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

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

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

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

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