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FDA OKs Opdivo for Head/Neck Carcinoma

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FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma o...

No Major Changes at FDA: Pines

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Former FDAer Wayne Pines outlines three impacts of the election results on FDA in the future.

Industry Seeks More Off-label Use Dissemination Freedom

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Drug and device industries urge FDA to revise its off-label dissemination policies to allow needed dialogs with payers and the med...

Group Wants FDA Warning on Dental Amalgam

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Consumers for Dental Choice asks FDA to take three steps to warn dentists, parents, and dental consumers against amalgam use in ch...

21st Century Cures May Be on Fast Track

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Political analysts see the possibility for compromise 21st Century Cures legislation to be approved by the lame duck Congress that...

Inspector General EpiPen Records Sought

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Sen. Chuck Grassley asks the HHS inspector general for records relating its 2009 determination that the EpiPen had been misclassif...

Botanical Drug Review MAPP Out

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CDER issues a MAPP on the review of INDs and NDAs for botanical drug products.

FDA Clears Syneron Medicals Profound Device

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FDA clears Syneron Medicals Profound microneedling device for improving cellulite appearance.

FDA Clears Joimax Probes

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FDA clears two Joimax electrosurgical probes.

Trump Expected to Bring Big Changes to FDA

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Notwithstanding president-elect Donald Trumps failure to publish a written policy platform, objective assessments of his public st...