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FDA Approvals - FDA Modifies Boxed Warning For Pulmonary Arterial Hypertension Drug Letairis


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 ...

Medtronic layoffs, cancer FDA approvals (Weekend Rounds)
Among the life science current events from last week: 2011 Medtronic layoffs, ViewRay FDA approval, Medtronic will try to divest Physio-Control, Pozen's new recruit from Biogen Idec, and a top GSK executive goes on video to talk about the company's future plans.

FDA approval process faulted at hearings on medical devices
The Food and Drug Administration is approving medical devices too slowly. Or too quickly - depending on whom you ask.
 

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