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Stelara Review Period Set

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Centocor Ortho Biotechs Stelara for the purpose of patent...

Panel to Discuss Bristol-Myers BLA to Treat Melanoma

[ Price : $8.95]

Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 2/9 to discuss Bristol-Myers Squibbs BLA for Yervoy for...

Panel to Discuss Bayer NDA for Diagnostic Imaging

[ Price : $8.95]

Federal Register Notice: FDAs Peripheral and Central Nervous Systems Drugs Advisory Committee will meet 1/20/11 to discuss Bayer H...

Cell Therapeutics Appeals Pixantrone NDA Rejection

[ Price : $8.95]

Cell Therapeutics files a formal appeal with CDER's Office of New Drugs to contest a Complete Response Letter on the companys NDA ...

Republicans Quiz Hamburg on Family Farm Ban for Employees

[ Price : $8.95]

Two prominent Republicans challenge a new FDA policy that bans employees from owning family farms.

First Drug to Prevent Lethal Horse Disease OKd

[ Price : $8.95]

FDA approves the first drug to prevent potentially lethal fescue toxicosis in horses, Dechra Veterinarys Equidone Gel (domperidone...

FDA Clears Conmed Thermal Tissue Fusion Device

[ Price : $8.95]

FDA clears Conmed Corp.s Altrus Thermal Tissue Fusion System for use in surgical procedures.

FDA Clears Elekta 510(k) for Proton Therapy

[ Price : $8.95]

FDA clears an Elekta 510(k) for its XiO treatment planning software to plan the proton therapy delivery method, spot scanning.

Guidance for Blood Establishments

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on recommendations for blood establishments to train back-up personnel, assess bl...

FDA Extends Review for Lupus BLA

[ Price : $8.95]

FDA extends by three months the review of a Human Genome Sciences BLA for Benlysta (belimumab), indicated for treating systemic lu...