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Orphan Drug Designation for ALD-101

[ Price : $8.95]

FDA grants orphan drug designation to Aldagens ALD-101 for decreasing time to platelet and neutrophil engraftment in patients unde...

FDA OKs ATS Medical Aortic Tissue Valve

[ Price : $8.95]

FDA approves an ATS Medical PMA for the ATS 3f Aortic Bioprosthesis, a stentless pericardial aortic tissue valve.

FDA Clears Cardo Medicals Knee System

[ Price : $8.95]

FDA clears a Cardo Medical 510(k) for the Align 360 Total Knee System.

Public Citizen Wants Avandia Banned

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Public Citizen petitions FDA to immediately ban GlaxoSmithKlines Avandia.

Another Tysabri PML Case Reported

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Biogen Idec says it has notified regulators of a new case of progressive multifocal leukoencephalopathy in a U.S. multiple scleros...

FDA Planning More BPA Research

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FDA says it is planning more research into low-dose effects of bispenol A.

FDA OKs Bards Flair

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FDA approves C.R. Bards Flair Endovascular Stent Graft to treat stenoses in synthetic arteriovenous bypass grafts.

Brochure Minimizes Sensipar Risk: DDMAC

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DDMAC says an Amgen Sensipar patient brochure omits and minimizes risk information and broadens the indication.

FDA Exclusivity Decisions Questioned

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Attorney Kurt Karst says FDA should reconsider its decision-making process on forfeiture of generic marketing exclusivity.

CBER, National Heart, Lung, and Blood Institute Sign MOU

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Federal Register Notice: FDA provides notice of a memorandum of understanding between CBER and NIHs National Heart, Lung, and Bloo...