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Advisors Unanimously Recommend Simeprevir Approval

[ Price : $8.95]

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...

Panel to Discuss Potential Pediatric Products

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/5 to the development of three products for potential pe...

FDA Clears New Hospira Infusion System

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FDA clears a Hospira 510(k) for the Sapphire infusion system.

FDA, Repros to Talk About Androxal Studies

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FDA tells Repros to request a teleconference to talk about clinical trials of its Androxal testosterone drug.