The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
Survodutide has a novel mechanism of action (agonism of the dual GCG/GLP-1 receptors) that may have direct effects on energy expenditure in the liver in addition to decreasing appetite
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
The drug exhibited greater treatment persistence and control of moderate-to-severe PsO symptoms compared to secukinumab and ixekizumab
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