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Nutra Pharma Ready to Launch Nyloxin

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Nutra Pharma says it will launch OTC and Rx versions of its pain reliever Nyloxin.

Cubist Ends Phase 2 Program on Safety Concerns

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Cubist Pharmaceuticals closes enrollment in its CB-500,929 (ecallantide) Phase 2 program, an investigational therapy for reducing ...

FDA OKs 2 Tris Pharma Anti-hypertensives

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FDA approves two Tris Pharma NDAs for once-daily clonidine extended-release suspension and tablets to treat hypertension.

Advisors Back Novartis Kidney Transplant Drug

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Members of FDAs Cardiovascular and Renal Drugs Advisory Committee say that Novartis Certican appears to be safe and effective in p...

FDA OKs Octapharma Anti-bleeding Therapy

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FDA approves Octapharmas wilate for treating spontaneous and trauma-induced bleeding episodes in patients with all types of von Wi...

Are the FDA Regional Offices a Value-added Function?

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Consulting editor John Scharmann reviews the history of FDAs regional offices and asks whether they have a value-added function.

FDAs Internet Communications Challenge: Macro vs. Micro

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FDA affairs commentator Steven Gross says the agency is on the wrong course in its efforts to develop an all-encompassing single p...

FDA Urges Attention to CT Perfusion Rad Dosage

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FDA says that facilities and CT technologists should take steps to ensure that patients undergoing CT perfusion scans are not expo...

FDA Says Silenor NDA Cant be Approved

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FDA again says that Somaxons NDA for Silenor to treat insomnia cannot be approved.

FDA Social Media Hearing Transcripts Available

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FDA releases its transcripts of last months two-day public hearing on social media.