Drug Approval | April 02, 2024
AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Application based on results from the TROPION-Breast01 Phase III trial
Application based on results from the TROPION-Breast01 Phase III trial
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
Combination shows consistent benefit across prespecified post-progression outcomes
Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK
Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager
The validations confirm the completion of the applications and commence the scientific review process
Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America
Acquisition includes HPN328, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager being evaluated in certain patients with small cell lung cancer and neuroendocrine tumors
Comprehensive clinical development programs being initiated for each investigational candidate
The company has received five final approvals
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