The FDA approved a new central nervous system stimulant called phentermine for weight loss in 1959. As an amphetamine analogue, phentermine , which is still in use today, has a lower risk of ...

FDA history doesn’t bode well for the future of a drug candidate from Cary-based Cornerstone Therapeutics (Nasdaq: CRTX). In this week’s print edition, I talked to Cornerstone Therapeutics CEO ...

An FDA advisory committee had voted 11-2 against approving Zohydro, a narcotic painkiller five to 10 times more powerful than Vicodin, Woodcock and the FDA instead pushed it through.

In January 2007, three and a half years after first finding problems at MDS, the FDA informed drug makers that studies done by MDS between 2000 and 2004 needed to be reevaluated.

Dec. 10, 2003: British drug regulators send a letter to doctors and health professionals advising against the use of almost all antidepressants in anyone under 18. The letter warns that new data ...

The FDA only banned DES prescriptions to women because no such problems have been found in men. In fact, it can still be prescribed to men to treat estrogen deficiency.

The drug was then approved in China, the United Kingdom and Sweden in the late 1980s and early 1990s. Then in 1999, nearly a dozen more countries approved mifepristone. The U.S. took its time on ...

In his new book, Mikkael Sekeres, MD, reflects on the history of the FDA and how the agency regulates drug approvals.

The FDA responded by doing something it's never done in its official 111-year history. The regulatory body immediately approved a label expansion for Keytruda to cover all cancers with this ...