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FDA Accelerated OK for Mercks Keytruda in Gastric Cancer

[ Price : $8.95]

FDA grants accelerated approval to Mercks Keytruda (pembrolizumab) for treating certain patients with recurrent locally advanced o...

FDA Approves MRI-friendly Labeling for Abbott ICD and Leads

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FDA has approved magnetic resonance-conditional labeling for Abbotts Ellipse implantable cardioverter defibrillator and associated...

FDA Complete Response on Janssen Arthritis BLA

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FDA issues Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active...

Draft Guide for Biosimilar Analytical Similarity Evaluations

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Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity.

Aegerion Pharma Pleading Guilty to Violating REMS

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Aegerion Pharmaceuticals agrees to plead guilty in the Massachusetts federal court to two misdemeanor misbranding charges involvin...

Public Citizen Sues FDA to Force Benzocaine Ruling

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Public Citizen asks the DC federal court to compel FDA to act on the advocacy groups petition asking that benzocaine not be permit...

Lawyer Faults New FDA Approach to 510(k)s

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Attorney Mark DuVal faults what he sees as FDAs new, less collaborative approach to determining whether a 510(k) is substantially ...

FDA Clears ClaroNav Surgical Navigation Device

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FDA clears a ClaroNav 510(K) for NaviENT, a computer-assisted surgical navigation system for surgical procedures inside a patients...

FDA Meeting on Antimicrobial Resistance Monitoring

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Federal Register notice: FDA announces a 10/24-25 public meeting entitled 2017 Scientific Meeting of the National Antimicrobial Re...

Workshop on Pediatric Drug Development for Heart Failure

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Federal Register notice: FDA announces a 10/27 public workshop entitled FDA-University of Maryland CERSI Drug Development in Pedia...