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Within days of President Obama signing the Drug Quality and Security Act, FDA posts three draft guidances on pharmacy drug compoun...[ Price : $8.95]
Baxter International files an amended BLA for HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] f...[ Price : $8.95]
FDA grants Conatus Pharmaceuticals an orphan drug designation for emricasan and its use in treating liver transplant recipients wh...[ Price : $8.95]
FDA grants 510(k) clearance to Sumitomo Heavy Industries for its Proton Therapy System to kill cancer cells.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget in a guidance on ...[ Price : $8.95]
Abbott recalls 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood gl...[ Price : $8.95]
FDA accepts for review an AcelRx Pharmaceuticals NDA for Zalviso (sublingual sufentanil microtablets), a patient-controlled treatm...[ Price : $8.95]
FDA extends by three months its review of a Biogen Idec BLA for Alprolix, an investigational long-lasting recombinant factor IX Fc...