Drug Approval | April 06, 2024
Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Trastuzumab deruxtecan (Enhertu) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer
The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris
Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
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