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FDA Tentative Approval for Generic Cymbalta

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FDA grants tentative approval to Impax Laboratories for a generic copy of Eli Lilly's antidepressant Cymbalta delayed-release (dul...

HHS Secretary Delegates Tobacco Authorities to FDA

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Federal Register Notice: The HHS secretary delegates authorities delegated to her under the Tobacco Control Act to the FDA commiss...

Joint Panel Meeting Canceled

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Federal Register Notice: A 12/2 joint meeting of the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Adv...

WV Appeals Court Reverses J&J Promotional Suit Decision

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A West Virginia appeals court reverses a lower court ruling and $4.5 million penalty against Johnson & Johnson for having allegedl...

Panel to Discuss Thromboxane Receptor Antagonists

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 12/8 to discuss clinical trial design fo...

FDA Warns About Viagra-containing Supplement

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FDA says Piston Corp.'s dietary supplement Vigor-25 illegally contains sildenafil, the active ingredient in Pfizer's Viagra.

BMS/Pfizer Halt Blood Thinner Trial

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Citing an increase in bleeding events, Bristol-Myers Squibb and Pfizer stop a Phase 3 study in patients with recent acute coronary...

FDA Approves Xgeva for Bone Cancer Patients

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FDA approves Amgen's Xgeva (denosumab) to help prevent skeletal-related events in patients with cancer that has metastasized and d...

FDA Demands Market Withdrawal for Old Pain Drug

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At FDA's request, Xanodyne Pharmaceuticals agrees to withdraw its propoxyphene pain drugs Darvon and Darvocet after new clinical d...

Ethicon Files BLA for Fibrin Pad

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Ethicon submits a BLA to FDA for the Fibrin Pad to aid in stopping soft tissue bleeding during surgery.