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FDA Clears Olympus Narrow Band Imaging Technology

[ Price : $8.95]

FDA clears an Olympus 510(k) for its Narrow Band Imaging to enable effective targeting of biopsies not seen under white light.

Animal Drug Regs Reflect Sept., Oct. Approvals

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Federal Register Notice: FDA is amending the animal drug regulations to reflect September and October approval actions for NADAs a...

FDA Withdraws Approval of Oxytetracycline ANADA

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Federal Register Notice: FDA withdraws approval of a Vetoquinol ANADA for oxytetracycline hydrochloride soluble powder.

FDA Study on Potential Changes for QT Cardiac Safety Studies

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An FDA co-designed study suggests that drug developers could conduct robust cardiac safety characterizations several years earlier...

FDAs First CLIA Waiver Goes to Syphilis Rapid Test

[ Price : $8.95]

FDA grants the first-ever Clinical Laboratory Improvement Amendments (CLIA) waiver for Veda Labs (Alencon, France) rapid screening...

ChemoCentryx Positive Phase 2 Data with Diabetic Nephropathy

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ChemoCentryx says a 52-week Phase 2 clinical trial involving its orally administered C-C chemokine receptor 2 antagonist CCX140 in...

FDA OKs MP Biomedicals HTLV Test

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FDA grants approval to MP Biomedicals for its MP Diagnostics Human T-Cell Lymphotropic Virus Blot 2.4, a Western Blot for HTLV con...

Senators Introduce Dormant Therapies Act

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Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) have introduced the Dormant Therapies Act, a bill that will establish a new ...

Court Orders Actavis to Continue Distributing Namenda

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New York Attorney General Eric T. Schneiderman wins a preliminary injunction against Actavis that requires the company to continue...

FDA Approves Sanofi Pasteurs Fluzone Quadrivalent

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FDA approves a Sanofi Pasteur supplemental BLA for Fluzone Intradermal Quadrivalent vaccine.