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 ...

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

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

Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...

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

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

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

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.

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 ...