The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
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
Growth team leads financing round in Cleveland Diagnostics; company to advance novel blood-based diagnostic technology to improve and lower costs for patients with cancer
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
The company has received marketing authorisation for docetaxel from Israel and cytarabine from Colombia
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