Immunotherapy and cell therapy have revolutionized the field of cancer treatment by harnessing the power of the immune system to fight cancer cells. However, the development of effective immunotherapy drugs such as immune checkpoint inhibitors requires extensive preclinical testing to ensure safety and efficacy. Breakthroughs in the field are faced with several challenges including the generation of appropriate humanized mouse models for preclinical evaluation. Among others, genetically-engineered mouse models have emerged as valuable tools for improving cancer treatment outcomes.
Genetically Engineered Humanized Mouse Models: A Critical Tool for Studying Immunotherapy Drugs
July 13, 2023
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The FDA has issued a new draft guidance titled “Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development.” This ...
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In June 2025, the FDA announced a major shift in regulatory guidance: the elimination of Risk Evaluation and Mitigation Strategy (REMS) requirements ...
The Rise of Humanized Mouse Models in Oncology: What Drug Developers Need to Know
Traditional mouse models remain a cornerstone of preclinical oncology research. Syngeneic and xenografts mouse models continue to play a critical ...
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