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

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

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

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

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

Looming threats to the pharmaceutical supply chain have brought fresh attention to onshoring. Experts say innovation is ...

Technology will soon make it possible to develop cheap, widely accessible psychoactive substances that are not harmful in the ...