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Panel to Discuss Genzyme sBLA for MS

[ Price : $8.95]

Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/13 to discuss a Genzyme ...

Draeger Anesthesia Machine Recall is Class 1

[ Price : $8.95]

FDA says a Draeger recall of Medical Fabius series anesthesia machines is Class 1.

B&L Whistleblower Gets 2nd Chance to Make Case

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The 11th Circuit appeals court returns to a lower court a Bausch & Lomb whistleblower case to determine if a causal connection exi...

Advisors Unanimously Recommend Simeprevir Approval

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Members of FDAs Antiviral Drugs Advisory Committee unanimously recommend approval of Janssens simeprevir in treating some cases of...

NPS Pharma Files BLA for Natpara

[ Price : $8.95]

NPS Pharmaceuticals submits a BLA for Natpara (recombinant human parathyroid hormone 1-84, rhPTH).

Increased Nanotechnology Regulatory Science Research Needed: CDER

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The CDER Nanotechnology Risk Assessment Working Group says increased nanotechnology regulatory science research and up-to-date tra...

FDA Breakthrough Status for Alexion Metabolic Disorder Drug

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FDA grants Alexion Pharma International a Breakthrough Therapy designation for its cyclic pyranopterin monophosphate, an enzyme co...

Researchers Suggest Models for Expanded Trial Data Sharing

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Researchers suggest four models that could accommodate increased calls for greater sharing of clinical trial data.

Merck Breakthrough Designation for Hepatitis C Therapy

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FDA grants Merck a breakthrough therapy designation for MK-5172/MK-8742 for treating chronic hepatitis C virus infection.

Pediatric Oncology Panel to Meet

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/4 to discuss FDAs position on patient-reported outcomes...