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Paragonix Files 510(k) for Heart Transplant Storage

[ Price : $8.95]

Paragonix Technologies files a Sherpa Pak Cardiac Transport System, intended for static hypothermic preservation of hearts during ...

Novartis Troubled Colorado Plant Passes FDA Inspection

[ Price : $8.95]

Novartis says a troubled plant in Colorado has just received a satisfactory FDA inspection, another sign that the firm is moving f...

RedHill Reports on Pre-NDA Meeting for Anti-Migraine Drug

[ Price : $8.95]

RedHill Biopharma and IntelGenx Corp. estimate an early 2013 NDA filing for its migraine drug RHB-103 after a reported successful ...

FDA OKs Janssen 800mg Prezista HIV Tablet

[ Price : $8.95]

FDA approves a Janssen Therapeutics supplemental NDA for an 800mg tablet of Prezista (darunavir), a once-daily oral drug for treat...

Advanced Sterilization Recalls Sterrad Biological Indicators

[ Price : $8.95]

Advanced Sterilization Products recalls all lots of its Sterrad Cyclesure 24 Biological Indicators manufactured between 2/2008 and...

Guidance on Nucleic Acid Based Diagnostic Devices

[ Price : $8.95]

Federal Register Notice: FDA is making available a draft guidance, Highly Multiplexed Microbiological/Medical Countermeasure In Vi...

FDA Panel Backs Novo Nordisk New Insulin

[ Price : $8.95]

FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to recommend approval of Novo Nordisk's new long-acting insulin d...

Baxter Recalls Buretrol Solution Sets

[ Price : $8.95]

Baxter Healthcare recalls its Buretrol Solution Sets because the devices ball-valve feature may not function as expected.

Mylan Inspection at PR Plant Cites Control Procedures

[ Price : $8.95]

An FDA inspection of Mylan Pharmaceuticals Caguas, Puerto Rico manufacturing facility finds issues with the firms manufacturing co...

FDA Approves Cordis Smart Control Vascular Stent

[ Price : $8.95]

FDA approves a Cordis PMA for the Smart Ccontrol Vascular Stent System for use in the superficial femoral artery and proximal popl...