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FDA Finds Potential Factor in IGIV Infusion Thrombosis

[ Price : $8.95]

FDA says it has identified a factor in some lots of immune globulin intravenous from several manufacturers that may increase the r...

Compliance Guide on OTC Bronchodilator Labeling

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Federal Register Notice: FDA releases a compliance guidance for small businesses on labeling for OTC bronchodilators.

AcelRx Pain System Meets Primary Endpoint

[ Price : $8.95]

AcelRx Pharmaceuticals reports that a Phase 3 study of its ARX-01 sublingual Sufentanil NanoTab PCA (patient-controlled analgesia)...

FDA Clears Semprus Bio Vascular Access Catheter

[ Price : $8.95]

FDA clears a Semprus BioSciences 510(k) for its vascular access catheter, Nylus Peripherally Inserted Central Catheter with Sempru...

FDA Panel Mixed on Heplisav Vaccine Effectiveness and Safety

[ Price : $8.95]

An FDA advisory committee votes 13 to 1 that a Dynavax Technologies BLA for Heplisav hepatitis B vaccine adequately demonstrated i...

FDA Approves Safety Labeling Changes for Statins, More

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FDA approves safety labeling changes for 58 drugs in October, including new Warnings for 13 statins.

38 States in $90 mil. Settlement with Glaxo for Avandia

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GlaxoSmithKline agrees to pay $90 million to 38 states to resolve allegations of illegal marketing of Avandia.

FDA OKs First Drug-eluting Stent for Pulmonary Artery Disease

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FDA approves Cook, Inc.s Zilver PTX drug-eluting peripheral stent, the first drug-eluting stent indicated to re-open the femoropop...

Phase 3 Study Shows Gileads Complera Non-Inferior to Atripla In HIV Patients

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Gilead Sciences says results of a Phase 3b study showed single tablet regimens of Complera as non-inferior to Atripla in treatment...

Guidance on Nucleic Acid Tests for Hepatitis B in Blood Donors

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Federal Register Notice: FDA releases a guidance on the use of nucleic acid tests to screen blood donors for hepatitis B virus.