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FDA Clears Crospon EndoFlip for Gastro Uses

[ Price : $8.95]

FDA clears a Crospon 510(k) for its EndoFLIP system and its use in gastroenterology applications.

Baxter Recalls Automix Nutrition Pumps

[ Price : $8.95]

FDA says Baxter Healthcare has initiated a Class 1 recall involving its Automix Automated Nutrition Compounder Systems due to inco...

FDA Approves Afinitor Pediatric Indication

[ Price : $8.95]

FDA approves Novartis Afinitor Disperz, a pediatric dosage form of Afinitor for use in treating patients age 1 and older with tube...

Battle for FDA Webview Surges Inside Agency

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FDA Webview editor Jim Dickinson attracts strong support in his battle to keep providing FDA employees with the unique interactive...

Oncologists Restrict Drug Reps More than Other MDs: Report

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A ZS Associates physician access report says that oncologists are restricting drug company sales reps more severely than any other...

FDA Panel Review Set for Dynavax Hep B Vaccine

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FDA sets an 11/14-15 advisory committee review for Dynavax Technologies and its BLA for Heplisav, a vaccine for preventing hepatit...

Advisors Recommend New Humira Indication

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FDA advisors say that Humiras benefits in treating ulcerative colitis outweigh its risks.

Genzyme Recalling 9 Thymoglobulin Lots

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CBER says Genzyme has recalled nine specific lots of thymoglobulin due to a stability test failure.

Alfa Vitamins Laboratories Selling Unapproved, Misbranded Drugs

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FDAs Florida District Office warns Alfa Vitamins Laboratories that the products it is marketing are considered drugs that have not...

Valeant Challenging In Vitro Zovirax Bioequivalence

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Valeant Pharmaceuticals asks FDA not to approve any generic Zovirax ointment ANDAs providing in vitro bioequivalence data.