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
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
WINREVAIR is a breakthrough biologic for this rare, progressive disease
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
Highlighting fully integrated organization, robust portfolio, and strategic priorities to drive long-term sustainable growth
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4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months
Submission to be reviewed under FDA real-time oncology review and Project Orbis
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