The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
This innovation enhances viral stability, preserves potency, and reduces allergic reactions and antigen crystallisation-related issues
The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026
UNLOXCYT is an evolution in checkpoint inhibition and is now available for the treatment of adults in the U.S. with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation
ALV-100 is a bifunctional fusion protein combining glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonism with glucagon-like peptide-1 receptor agonism
The mPTP plays a key role in mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative diseases
The approval is backed by data showing deep, durable responses and manageable tolerability
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
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