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PharmaPendium, Elsevier announces a new release that adds extensive FDA Advisory Committee content to the online resource for authoritative preclinical, clinical and post-market drug information. These documents provide preclinical and clinical drug development and regulatory affairs departments with a substantial collection of comparative scientific and regulatory data that may not be included in final FDA Approval Package documents.
Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate, a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.
Results of a Schering-Plough Corporation Phase II trial of SCH 530348, a novel oral thrombin receptor antagonist (TRA), were published today in The Lancet and demonstrated that the investigational antiplatelet compound met its primary endpoints of safety and tolerability.
Seattle Genetics, Inc. announced today that the validation period is complete and Health Canada has accepted for review its New Drug Submission (NDS) for the use of ADCETRIS (brentuximab vedotin) in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma.
Symmetry Medical Inc., a leading independent provider of products to the global orthopaedic device industry and other medical markets, announced today a restructuring that includes a facility consolidation and other staff reductions designed to increase operational efficiency and drive annualized cost savings.
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