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The FDA's concerns cite peptide manufacturing risks: incompletely characterised active ingredient, peptide fragments, degradation products, and impurities that the immune system may recognise as foreign

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The study focused on 5 specific immune-related adverse events, based on the National Comprehensive Cancer Networks (NCCN) guidelines for the management of immunotherapy-related toxicities, version 1.2020, including diarrhea/colitis, kidney injury, pneumonitis, thyroid disorder, and transaminitis