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FDA Orders Marshals to Seize Unapproved Drug Products

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U.S. marshals seize various unapproved and improperly labeled drug products that were marketed on the Web by Flawless Beauty (Asbu...

FDA Grants Orphan Status for Huntington Drug

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FDA grants Prana Biotechnology an orphan drug designation for PBT2 and its use in treating Huntington Disease.

Court Gives Depomed Win Over FDA in Orphan Drug Dispute

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The Washington DC federal district court grants Depomed summary judgment compelling FDA to award Gralise (gabapentin) orphan drug ...

FDA OKs Keryx Bios Ferric Citrate in Dialysis Patients

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FDA approves Keryx Biopharmaceuticals ferric citrate for controlling serum phosphorus levels in patients with chronic kidney disea...

FDA Accepts Actavis NDA for UTIs, Abdominal Infections

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FDA accepts for filing an Actavis NDA for ceftazidime-avibactam for treating patients with complicated urinary tract infections an...

FDA Lifts Clinical Hold on OncoMed Cancer Therapy

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FDA removes a partial clinical hold against OncoMed Pharmaceuticals ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trial in canc...

FDA Allows Marketing of Kidney Injury Test

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FDA approves an Astute Medical de novo petition to allow marketing of the NephroCheck test, a lab test designed to help determine ...

FDA Clears Esaote Ultrasound System

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FDA clears an Esaote North America 510(k) for its MyLab Six ultrasound system.

Customed Recalls Surgical Packs Due to Sterility Concerns

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Customed recalls multiple surgical packs manufactured between 1/2009 and 5/2014 due to sterility concerns.

Wheelchair Reclassification Bid Needs More Info

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FDA asks Canadas Adaptive Engineering for more information to support its petition request for a Class 2 exemption for its portabl...