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FDA Issues CRL to BLA of OBI Presentation of Pegfilgrastim-cbqv
September 25th 2023The FDA has issued a complete response letter for the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, but has not requested additional findings or clinical trials.
Phase 2 SCOPE Trial of SCIB1 Achieves Positive ORR in Advanced Melanoma
September 21st 2023Positive objective response results were demonstrated in the first stage of the phase 2 SCOPE trial. Now, 27 additional patients with advanced melanoma will be treated with SCIB1 and checkpoint inhibitors in stage 2.
Biological Factors Affect CDK4/6 Inhibitor Response in Breast Cancer
September 20th 2023Results from a new study could lead to the development of biomarkers for predicting treatment response and the implementation of strategies to address acquired resistance of CDK4/6 inhibitors in HR-positive/HER2-negative breast cancer.