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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.
FDA Grants Priority Review to Pembrolizumab/Chemoradiotherapy in Cervical Cancer
September 20th 2023A supplemental biologics license application seeking the approval of pembrolizumab, external beam radiotherapy, and concurrent chemotherapy, followed by brachytherapy has been accepted for priority review by the FDA for advanced cervical cancer.