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After Election, Agency Could Face Budget Cuts: FDA Alliance

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The Alliance for a Stronger FDA says the agency could face significantly lower appropriations for FY 2011 when Congress returns af...

FDA Wants More Linjeta Info

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FDA says Biodel should conduct new Phase 3 trials of its Linjeta to establish efficacy and safety in treating Types 1 and 2 diabet...

FDA, University of Rochester Partnering to Streamline Drug Process

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FDA says it is partnering with the University of Rochester to advance regulatory science by addressing scientific information gaps...

FDA OKs Medtronic Thoracic Stent Graft

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FDA approves Medtronics Talent Thoracic Stent Graft with Captivia Delivery System used in the endovascular repair of thoracic aort...

Neogenix Oncology 'Orphan' Status on Pancreatic Cancer Drug

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FDA grants Neogenix Oncology an orphan drug designation for ensituximab (monoclonal antibody NPC-1C) for treating pancreatic cance...

NuPathe Files NDA for Migraine Patch

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NuPathe files an NDA for Zelrix (sumatriptan), a transdermal patch for treating migraine headaches.

New Indication Approved for Novartis Afinitor

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FDA approves a new indication for Novartis Afinitor for treating patients with subependymal giant cell astrocytoma associated with...

FDA OKs Dechra NADA for Mares

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Federal Register Final rule: FDA approves Dechra Ltd.s NADA for veterinary prescription use of domperidone oral gel for preventing...

Panels to Discuss Endo NDA for Pain Relief

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Federal Register Notice: FDAs Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees will m...

FDA Sends 'Rejection' Letter on Vivus Weight-loss Drug

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FDA sends Vivus a complete response letter denying approval of its NDA for weight-loss drug Qnexa (phentermine/topiramate) control...