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QS Violations Found at bioMerieux Facility

[ Price : $8.95]

FDAs Atlanta District Office warns bioMerieux about Quality System violations in its Durham, NC, diagnostic device manufacturing f...

FDA Says Lancome Marketing Unapproved Drugs

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FDA warns Lancome USA that many products sold through its Web site are considered drugs that dont have agency approval.

FDA Lymphoseek Complete Response Letter

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FDA issues a complete response letter for Navidea Biopharmaceuticals Lymphoseek NDA.

FDA Has New Device to Detect Counterfeit, Bad Products

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FDA unveils a new, agency developed and manufactured hand-held device, employing LED technology, for rapid identification of count...

FDA Clears Precision Spine Cervical Plate System

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FDA clears a Precision Spine 510(k) for the Slimplicity Solo Anterior Cervical Plate System for use in cervical spine procedures.

Geron Discontinues Imetelstat Breast Cancer Trial

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Geron stops a randomized Phase 2 study involving imetelstat in metastatic HER2-negative breast cancer because median progression-f...

FDA Clears Abiomed Impella CP

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FDA clears an Abiomed, Inc. 510(k) application for the Impella CP, a percutaneous catheter-based heart pump.

FDA Withdraws 4 NADAs

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Federal Register Final rule: FDA amends the animal drug regulations to withdraw four NADAs that are no longer marketed.

FDA Fast Track for 'Flesh-eating' Bacteria Treatment

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FDA grants a fast track designation to Atox Bio for AB103, which if approved could be the first U.S. treatment for necrotizing sof...

LA Appeals Court Upholds $258 Million Award Against Janssen

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A Louisiana appeals court confirms a $257.7 million jury verdict against Janssen Pharmaceutical for defrauding Medicaid.