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Tag Archives: tumors
FDA Reorganizes Oncology and Hematology Divisions
When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged CDER, FDA, hematology, marketing application, oncology, toxicology, tumors
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Approval of Therapeutic Cancer Vaccines
Last month, Dendreon was granted approval for Provenge®, the first cell based cancer vaccine for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Provenge is the first cancer treatment that utilizes the strength of the … Continue reading
Posted in FDA, Industry News, Publications
Tagged biomedical, cancer, Cancer Advances, cancer vaccine, Cato BioVentures, clinical benefit, clinical development, Dendreon, drug development, gastric cancer, gastrointestinal cancers, immune system, immunomodulators, Journal for Clinical Studies, monoclonal antibody therapy, pancreatic cancer, Provenge, serum-derived polyclonal treatment, targeted therapeutics, tumors
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