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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

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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

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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

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

Ex-Sebelius Aide Purges FDA Press Office

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In an unprecedented purging of career staff under her, new FDA associate commissioner for external affairs Beth Martino, 31, remov...

FDA Panel Backs Fecal Incontinence PMA

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FDA's Gastroenterology and Urology Devices Panel votes to recommend approval of an Oceana Therapeutics PMA for Solesta, a bulking ...

Reviewers Raise Safety Concerns on Orexigen Weight-loss NDA

[ Price : $8.95]

FDA reviewers say there are cardiovascular safety concerns associated with the potential approval of Orexigen's proposed weight-lo...