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Results For "clinical-development"

548 News Found

Enveric clears FDA feedback milestone, prepares IND submission for EB-003
Clinical Trials | September 17, 2025

Enveric clears FDA feedback milestone, prepares IND submission for EB-003

IND application for EB-003 expected in early 2026


FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers
Drug Approval | September 16, 2025

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo


iRegene Therapeutics secures series B+ financing
Biotech | September 12, 2025

iRegene Therapeutics secures series B+ financing

NouvNeu001 is the world’s first allogeneic iPSC-derived cell therapy for Parkinson’s disease to receive this designation


Argo Biopharma inks $5.2 billion deal with Novartis for novel molecules for cardiovascular diseases
News | September 08, 2025

Argo Biopharma inks $5.2 billion deal with Novartis for novel molecules for cardiovascular diseases

Argo will receive an upfront payment of $160 million, an option for Profit & Loss split across multiple geographies and potential near-term equity


Glenmark initiates multi-country Phase 3 clinical trial for Envafolimab in resectable Stage III NSCLC
Clinical Trials | September 06, 2025

Glenmark initiates multi-country Phase 3 clinical trial for Envafolimab in resectable Stage III NSCLC

The company has received approval from DCGI to begin patient enrolment and dosing in the country


Merck appoints David Weinreich as new Global Head of R&D and CMO for Healthcare Business
People | September 03, 2025

Merck appoints David Weinreich as new Global Head of R&D and CMO for Healthcare Business

He has successfully led the development of 15 approved drugs worldwide across various therapeutic areas over his more than 20-year career


Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China
News | August 30, 2025

Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China

Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)