Implementation of the Clinical Trials Regulation in the EU and EEA
The Clinical Trials Information System will become mandatory for all authorisation application for a clinical trial in the EU on 31 January 2023
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The Clinical Trials Information System will become mandatory for all authorisation application for a clinical trial in the EU on 31 January 2023
Evidence for efficacy is based on the results from the GO29781 study
Findings from the ongoing KRYSTAL-1 phase I/II study in patients with metastatic colorectal cancer with a KRAS G12C mutation
Findings from the phase I and phase II portions of the CodeBreaK 100 study
It is the first drug to receive a labelling update under Project Renewal
New indications concern the combination treatment of metastatic non-small cell carcinoma and of advanced or unresectable hepatocellular carcinoma
New indication concerns the treatment of unresectable or metastatic HER2-low breast cancer
Different molecular subtypes of appendiceal adenocarcinomas have distinct clinical and biological behaviours that may be useful in guiding therapeutic decision
Findings from a combined analysis of SOFT-TEXT after a median follow-up of 13 years
Glofitamab induces durable complete responses in patients with relapsed or refractory diffuse large B-cell lymphoma
FDA also approved the QIAGEN therascreen KRAS RGQ PCR kit (tissue) and the Agilent Resolution ctDx FIRST Assay (plasma) as companion diagnostics
Evidence for efficacy is based on the results from the Study ML39345
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