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K-V Pharma Asks Court to Make FDA Block Makena Compounding

[ Price : $8.95]

K-V Pharmaceutical asks the Washington, DC federal appeals court to compel FDA to prevent Chinese unapproved ingredients from ente...

Alexion Updates Recall of 2 Soliris Lots

[ Price : $8.95]

Alexion Pharmaceuticals updates its earlier recall involving two lots of Soliris (eculizumab) concentrated solution for intravenou...

CDRH Tweaks Medical Device Recall Database

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CDRH says it has made improvements to several public medical device recall databases.

Genzyme, NORD Fund for Rare Disease Diagnostic Testing

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Genzyme and the National Organization for Rare Disorders create a fund to pay for standard diagnostic testing for people with myst...

FDA Amends Animal Drug Regs on Dairy Heifers and Bambermycins

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Federal Register Final rule: FDA is removing dairy replacement heifers from the pasture cattle class for which free-choice, loose-...

Info on Pediatric Devices Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on pediatric uses of devices to the Office of Management...

Advisory Committee Backs BMS Diabetes Drug

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommends that the benefits of Bristol-Myers Squibbs diabetes drug dap...

FDA Wants More Data on Janssen Combo Diabetes Drug

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FDA issues Janssen a complete response letter on its NDA for a fixed-dose combination of canagliflozin and immediate-release metfo...

House Lawmakers Introduce Antibiotic Development Bill

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A bipartisan group of U.S. House lawmakers introduces the Antibiotic Development to Advance Patient Treatment Act of 2013.

Cadence Seeks Approval Restrictions on Generic Ofirmev Products

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Cadence Pharmaceuticals petitions FDA asking it not to approve any generic or 505(b)(2) NDAs for an acetaminophen solution for int...