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FDA Clears Disposable Insulin-delivery Device

[ Price : $8.95]

FDA clears a Valeritas 510(k) for the V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin.

McNeil Wants High Court Review of OTC Preemption Case

[ Price : $8.95]

McNeil asks the Supreme Court to decide whether federal law preempts state failure-to-warn suits for OTC drugs.

Feds Creating Drug Development Center

[ Price : $8.95]

NIH recommends creating a new federal center to partner with industry in drug development.

Special Protocol Assessment Reached for Prostate Cancer Vaccine

[ Price : $8.95]

FDA and Bavarian Nordic A/S reach agreement on a Special Protocol Assessment for a Phase 3 study involving the vaccine Prostvac, i...

Kos Paying $41 Million to Settle Charges

[ Price : $8.95]

Kos Pharmaceuticals agrees to pay $41 million to resolve whistleblower anti-kickback and false claims suits.

FDA Posts Safety Labeling Changes to 37 Products

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FDA approves safety labeling changes for 37 drugs, including anaphylactic reactions for 10 neuromuscular blockers.

FDA Funds IoM Review on Pediatric Studies

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FDA funds a new Institute of Medicine review on pediatric drug and biologic studies requested under the Best Pharmaceuticals for C...

Penumbra Recalls Reperfusion Catheter 032

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Penumbra recalls 77 reperfusion catheter 032s due to a manufacturing error that endangers patients experiencing stroke.

FDA OKs Agri Labs sANADA for Dairy Cows

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Federal Register Final rule: FDA approves an Agri Laboratories sANADA for use of flunixin meglumine solution for control of pyrexi...

FDA OKs Huvepharma ANADA for Bacterial Diseases

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Federal Register Final rule: FDA approves a Huvepharma ANADA for using tylosin tartrate in drinking water to control various bacte...