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

Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing ...

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

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

Australia's drug approval system is under fire, with critics in the United States claiming it is too slow to approve ...