EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
The validations confirm the completion of the applications and commence the scientific review process
The validations confirm the completion of the applications and commence the scientific review process
The overall transaction is expected to conclude over next 12-15 months subject to receipt of all relevant shareholder and regulatory approvals
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
Highlighting fully integrated organization, robust portfolio, and strategic priorities to drive long-term sustainable growth
The acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting antithymic stromal lymphopoietin (TSLP) monoclonal antibody
he lower sales in the current quarter are mainly on account of a one?time impact on the company’s India business
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway
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