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FDA Approves Crush-resistant Opana ER

[ Price : $8.95]

FDA approves a crush-resistant formulation of Endo Pharmaceuticals pain drug Opana ER (oxymorphone).

FDA Clears Meridian Bio Group B Strep Test

[ Price : $8.95]

FDA clears a Meridian Bioscience 510(k) for a new molecular diagnostic test for Group B Streptococcus on its illumigene platform.

Fast Track for Celladon Heart Failure Drug

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FDA grants fast track status to Celladon Corp. for its investigational drug Mydicar and its use in treating advanced heart failure...

Public Citizen Dismisses Clinical Trial Revamp Proposal

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Public Citizen says a proposal published in Science by former Intel CEO Andrew Grove to restructure clinical trials in the U.S. is...

2 More Studies Find No Increased CV Risk with ADHD Meds

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FDA says two new large studies involving drugs used for treating Attention-Deficit/Hyperactivity Disorder (ADHD) have not shown an...

FDA, EMA Begin Sharing Inspection Reports

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FDA and the European Medicines Agency begin next month relying on each others GMP surveillance inspection reports for certain drug...

FDA OKs Lannett Generic Antihypertensive

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FDA approves a Lannett ANDA for triamterene with hydrochlorothiazide 37.5/25 mg capsules, a generic of SmithKline Beechams Dyazide...

Nektar Breast Cancer Drug Enters Phase 3 Trial

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Nektar begins a Phase 3 global clinical trial to evaluate its NKTR-102 as a single agent in women with metastatic breast cancer.

FDA Identifies Shortcomings in Onyx NDA for Carfilzomib

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FDA says it has potential review concerns after assigning a 12-month standard review for an Onyx Pharmaceuticals NDA for carfilzom...

Info on DTC Advertising Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the experimental study of comparative direct-to-consu...