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Judge Orders Compassionate Drug Use

[ Price : $8.95]

Federal judge William Martini orders PTC Therapeutics to provide one of its experimental drugs to a particular duchenne muscular d...

FDA Clears XDx AlloMap Heart Assay

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FDA clears XDx AlloMap diagnostic multivariate assay to help determine if heart transplant patients are likely to reject the new o...

Priority Review for New Gleevec Indication

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FDA says it will give priority review to Novartis Gleevec for a new indication for use after surgery in kit-positive gastrointesti...

Draft Integrated Summary of Effectiveness Guidance Out

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FDA issues a draft guidance superseding 1988 information on preparing an integrated summary of effectiveness for an NDA or BLA.

Obama Vows to Strengthen FDA

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Barack Obama says he wants FDA staffed with the best scientists and experts who will focus on approving safe drugs and not on help...

FDA Clears TomoTherapy Radiation Therapy

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FDA clears a TomoTherapy 510(k) for the TomoDirect radiation therapy technology.

FDA Clears Aperio Image Applications

[ Price : $8.95]

FDA clears Aperio Technologies ER and PR immunohistochemistry image analysis applications.