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Pfizer, GSK Cooperating in Cancer Drug Study

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Pfizer and GlaxoSmithKline agree to cooperate on a cancer combination drug trial involving a drug from each of the companies.

Settlement Brings Louisiana $88 Million from Drug Firms

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25 drug companies agree to pay Louisiana $88 million to resolve claims they overcharged Medicaid for prescription drugs.

FDA OKs Biotronik Trial of Pacing System with MRI

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FDA approves an expansion of Biotroniks ProMRI trial that will evaluate the safety and efficacy of its existing pacemaker systems ...

Deseo Rebajar Recalling 1 Adipotrim XT Lot

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Deseo Rebajar recalls one lots of its Adipotrim XT weight loss dietary supplement that contains the undeclared antidepressant fluo...

Pfizer Wins Full Approval for Xalkori in Lung Cancer

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FDA grants Pfizer regular approval for Xalkori (crizotinib) for treating patients with metastatic ALK-positive non-small cell lung...

22 Representatives Want FDA, Others Protected from Sequestration

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Some 22 House members say any budget agreement should include a provision exempting fee-based agencies such as FDA from sequestrat...

FDA Accepts Omeros NDA, Name for IOL Surgery Product

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FDA accepts an Omeros Corp. NDA and proposed brand name for a product in development for use in intraoperative lens replacement su...

Comments Extended on Cellular/Gene Therapy Product Trials

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Federal Register Notice: FDA extends the comment period for a guidance entitled Considerations for the Design of Early-Phase Clini...

Guidance on Name Placement in Advertising

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Federal Register Notice: FDA releases a draft guidance, Product Name Placement, Size, and Prominence in Advertising and Promotiona...

FDA Clears Boston Scientific Microcatheter

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FDA clears a Boston Scientific 510(k) for its Direxion Torqueable Microcatheter for use in peripheral embolization surgeries.