FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts sBLA for Subcutaneous Orencia

[ Price : $8.95]

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

Vivus Plans 2011 NDA for Erectile Dysfunction Drug

[ Price : $8.95]

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

Cubist Petition Seeks to Slow Generic Cubicin Approvals

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

DDMAC Again Cites an Allergan Lumigan Promo

[ Price : $8.95]

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

[ Price : $8.95]

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

Comments Sought on Exports Not Approved in U.S.

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on requirements for persons exporting products that may not be marketed in the U.S.

Guidance on Transmission of T. cruzi

[ Price : $8.95]

Federal Register Notice: FDA sends to the Office of Management and Budget and releases a guidance: Use of Serological Tests to Red...

Review Period Set for B & Ls Besivance

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Bausch & Lombs Besivance for the purpose of patent extens...