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FDA Accused of Stacking Advisory Panel to Favor Amalgam

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Again balking at efforts to induce transparency, FDA maintains silence on charges that it has stacked next weeks public advisory p...

FDA Denies Delmont Labs Hearing on Bacterial Antigens

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Federal Register Notice: FDA is denying a request by Delmont Labs for a hearing on a proposal to revoke the companys license based...

Sequella Files IND for H.pylori-related ulcers

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Sequella files an IND with FDA to test SQ109 in patients with H. pylori-related duodenal ulcers.

FDA Accepts sBLA for Subcutaneous Orencia

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FDA accepts for review a Bristol-Myers Squibb supplemental BLA for a subcutaneous formulation of Orencia (abatacept).

Cubist Petition Seeks to Slow Generic Cubicin Approvals

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Cubist Pharmaceuticals petitions FDA to block approval of generic Cubicin (daptomycin) until potential ANDA submissions meet certa...

FDA Panel Backs Wider Use of Gastric Band

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FDA's Gastroenterology and Urology Devices Panel votes to recommend wider use for Allergan's LAP-Band System for weight reduction ...

FDA Press Officers Stole Our Freedom: Dickinson

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In a new Columbia Journalism Review article, FDA Webview editor Jim Dickinson tells how government press officers stole our freedo...

Vivus Plans 2011 NDA for Erectile Dysfunction Drug

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Vivus says it is planning a second quarter 2011 NDA submission for its erectile dysfunction drug TA-314 (avanafil) after reporting...

DDMAC Again Cites an Allergan Lumigan Promo

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DDMAC says Allergan should stop using a Lumigan mailer directed at healthcare professionals because it allegedly contains unsubsta...

Seattle Genetics BLA Planned for Lymphoma Therapy

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Seattle Genetics says it plans a first quarter 2011 BLA for brentuximab vedotin (SGN-35) for treating relapsed or refractory Hodgk...