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
Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America
The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union
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