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Results For "clinical-development"

521 News Found

Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer
Clinical Trials | September 23, 2025

Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer

Importantly, the combination of giredestrant and everolimus was well tolerated


FDA approves Merck's Keytruda injection for cancer therapy
Drug Approval | September 21, 2025

FDA approves Merck's Keytruda injection for cancer therapy

Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute


Datavant partners with Indegene to power clinical trial recruitment
Digitisation | September 21, 2025

Datavant partners with Indegene to power clinical trial recruitment

Collaboration matches more eligible patients, including those with rare and complex diseases, to appropriate clinical trials


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