Strategy-Launch and Pre-Launch Clinical Trials

The biotechnology company reported a successful trial for an experimental osteoporosis drug that reduced the risk of bone fractures in post-menopausal women.

A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it.

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Clinical trials aggressively recruiting test subjects with billboards, posters

...earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials...

...approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

Only drug available in United States for irritable bowel syndrome with constipation

Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies...