U.S. Approvals of Supplemental Drug Indications Have Been Rising Steadily, According to Tufts Center for the Study of ...
BOSTON, MA--(Marketwire - 03/08/11) - New or modified indication approvals for existing prescription drugs have steadily increased in the United States since the late 1990s, according to an analysis recently completed by the Tufts Center for the Study of Drug Development. The number of new or modified indication approvals -- consent by the Food and Drug Administration (FDA) to market drugs for ...

Biotech Calendars: 2011 FDA Drug Approvals
BOSTON (TheStreet) -- I've updated the 2011 FDA drug approval calendar. For easy reference, I've organized this regulatory calendar in chronological order based on the drug approval decision date. I've also included information on pending FDA advisory panels. At the end of the calendar is a list of companies with potential regulatory milestones in 2011 based on expected but not yet completed ...

FDA Modifies Boxed Warning For Pulmonary Arterial Hypertension Drug Letairis
The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH). Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver ...