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Abiomed Faces Probe on Impella Marketing

[ Price : $8.95]

Abiomed says the United States Attorney's Office for the District of Columbia is conducting an investigation focused on its market...

Pew Wants Stronger Animal Antibiotic Regs, Reporting

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The Pew Charitable Trusts says that FDA should strengthen its requirements for animal antibiotic regulation and reporting.

Aerie Reports Positive Results for Glaucoma Drug Combo

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Aerie Pharmaceuticals reports positive Phase 2a clinical trial results from a combination of its Rho kinase inhibitor AR-12286 wit...

Markey Releases Draft of Compounding Act

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Rep. Edward J. Markey (D-MA) releases draft legislation he intends to introduce 11/2 to give FDA more authority to regulate compou...

Additional Recalled NECC Drugs Show Contamination

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FDA and CDC say bacterial contamination was found in two additional recalled NECC products.

FDA Complete Response on Cornerstone Therapeutics NDA

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FDA issues Cornerstone Therapeutics a complete response letter on its NDA for lixivaptan, indicated for treating symptomatic hyper...

New Approach Suggested for Generic Drug Adverse Event Liability

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Researchers say a new approach is needed to ensure updated safety information on generic drug labels and compensate patients who s...

FDA Sets 6/15/2013 User Fee Date for Delcath Systems NDA

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FDA sets a 6/15/2013 user fee review action target date for a Delcath Systems NDA for its proprietary chemosaturation system with ...

Phase 3 Trial Initiated in Hodgkin Lymphoma

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Millenium: The Takeda Oncology Co. and Seattle Genetics initiate a Phase 3 clinical study of Adcetris as part of a chemotherapy re...

CDER Clarifies New Policy on Extended-release Generics

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FDAs order last month for Teva to withdraw its generic bupropion extended-release 300mg product prompts the agency to pay closer a...