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FDA clears a Spine Wave 510(k) for the StaXx XDL Expandable Device, a PEEK (polyetheretherketone) spacer for use in spinal surgeri...[ Price : $8.95]
FDA sends Novartis a complete response letter on a BLA for Ilaris (canakinumab) and its use in gouty arthritis patients.[ Price : $8.95]
Shionogi Pharma and Cima Labs file a patent infringement suit against Mylan Pharmaceuticals over an ANDA it submitted for a generi...[ Price : $8.95]
Consulting editor John Scharmann reports on current expansion of FDAs field staff and investigational capabilities.[ Price : $8.95]
A new FDA drug safety alert says Sanofi-Aventis Anzemet (dolasetron mesylate injection) should no longer be used to prevent nausea...[ Price : $8.95]
FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for use in treating drug refractory paroxysmal atrial f...[ Price : $8.95]
FDA sends AstraZeneca a complete response letter on its NDA for Brilinta (ticagrelor), requesting an additional analysis of clinic...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on Application for FDA Approval to Market a New Drug.