The odds of shepherding a new drug to market in recent years has fallen to nearly one in 10 — about half of the previous rate, according to a new study released this week. First, a new treatment must survive several layers of …
From October 2010 to February 2011, biotech Clinical Data’s stock doubled, mostly thanks to FDA approval of its novel antidepressant. But also pushing the stock up — and making it likely to perhaps double again — is speculati…
In a surprise move Tuesday, the FDA rejected Orexigen’s proposed new diet drug Contrave, saying the company needed to run another study of its cardiovascular risks. With this rejection, all three of a slate of similar diet drug…
The FDA disappointed AstraZeneca and its investors by not approving its heart drug Brilinta, a blood-thinner that the company — facing a severe patent cliff — has high hopes for. If approved, it could be a multibillion-dollar…
More than a year after AstraZeneca filed for approval, the FDA will make its decision on Thursday. A large study showed the blood thinner worked better than Plavix for treating acute coronary syndrome — but approval isn’t a su…