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
Application based on results from the TROPION-Breast01 Phase III trial
Executes the first project for developing and manufacturing a novel anticancer mAb
Under this agreement, lpca will grant to Omexa a non-exclusive right to research, develop, manufacture and market an anti-cancer biosimilar for the global market
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+
Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
The validations confirm the completion of the applications and commence the scientific review process
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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
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