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FDA approves a GlaxoSmithKline BLA for Fluarix Quadrivalent (influenza virus vaccine) for the immunization of children (three year...[ Price : $8.95]
A new Congressional Research Service report on FDAs biosimilars pathway finds that navigating the approval path will be an arduous...[ Price : $8.95]
FDA grants fast track status to Lexicon Pharmaceuticals for LX1033, an orally-delivered small molecule drug candidate for diarrhea...[ Price : $8.95]
Antares Pharma submits an NDA for Otrexup, a combination product for delivering methotrexate using Medi-Jet technology.[ Price : $8.95]
Citing regulatory science advancements, FDA denies a Valeant Pharmaceuticals citizen petition asking the agency to not approve any...[ Price : $8.95]
An FDA drug safety alert reminds healthcare professionals and patients that Jazz Pharmaceuticals Xyrem should not be used in combi...[ Price : $8.95]
FDA clears a Quidel Corp. 510(k) for its non-instrumented molecular diagnostic test, the AmpliVue C. difficile Assay.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on information to accompany humanitarian device exemption applications.