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 ...

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

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

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

Karnataka's Food Safety and Drug Administration enforced strict measures against drug and food safety violations, suspending ...

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

The anti-seizure drug is used to treat epilepsy, nerve pain after shingles and restless legs syndrome by affecting chemical messengers in the brain and nerves.

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

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

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