Quality of biomarker defined subgroups in FDA approvals of PD‐1/PD‐L1 inhibitors 2014 to 2020
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DOI: 10.1002/ijc.33968
Abstract: PD‐L1 expression is associated with differential response in cancers treated with checkpoint inhibitors. Clinical trials for Food and Drug Administration (FDA) approvals of programmed death receptor‐1 (PD‐1)/programmed death ligand‐1 (PD‐L1) inhibitors include limited subgroup analyses… read more here.
Keywords: approval; fda approvals; biomarker; clinical trials ... See more keywords
Analysis of the overall survival and main surrogates used for FDA approvals in solid and haematological malignancies
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DOI: 10.1093/annonc/mdz244.048
Abstract: Abstract Background U.S. Food and Drug Administration (FDA) approves drugs based on overall survival (OS) in oncology trials in order to speed up access of novel drugs to the market. Methods We examined all adult… read more here.
Keywords: fda approvals; overall survival; oncology; subsequent lines ... See more keywords
FDA Approvals of Biologics in 2022
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DOI: 10.3390/biomedicines11051434
Abstract: The year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and… read more here.
Keywords: year; fda approvals; biologics 2022; previous years ... See more keywords