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FDA Approves Alexions Kanuma for Rare Disease

[ Price : $8.95]

FDA approves an Alexion Pharmaceuticals BLA for Kanuma (sebelipase alfa), the first treatment for patients with the rare disease l...

FDA Clears Battlefield Wound Dressing for Civilian Use

[ Price : $8.95]

FDA clears a RevMedX 510(k) for the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-thr...

FDA Panel to Review Codeine Safety in Children

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FDA convenes a joint meeting of its Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Commit...

Court Tries to Define Clear Evidence in Preemption Case

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Attorney Emily Pincow says that a California federal court ruled that there can be clear evidence that FDA would reject a proposed...

FDA Approves 1st Recombinant von Willebrand Factor

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FDA approves Baxaltas Vonvendi as the first approved recombinant von Willebrand factor for use in treating and controlling bleedin...

FDA Clears Qfix Encompass Stereotactic Radiosurgery Device

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FDA clears a Qfix 510(k) for the Encompass SRS Immobilization System for use in stereotactic radiosurgery.

IDE Approved for StimRelieve Trial of Pain Device

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FDA approves a StimRelieve IDE for the company to launch a clinical trial of what it describes as the worlds smallest percutaneous...

Bayer Asks FDA for Stricter BE Requirements for Mirena

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Bayer petitions FDA asking that it institute strict bioequivalence requirements before approving any ANDA for a generic copy of it...

Workshop on Device Cybersecurity

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Federal Register Notice: FDA plans a public workshop 1/20-21/16 entitled: Moving Forward: Collaborative Approaches to Medical Devi...

Group Asks FDA Not to Approve Gout Drug

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Public Citizen urges FDA not to approve AstraZenecas lesinurad oral tablets for treating hyperuricemia associated with gout becaus...