Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
The initiative was announced at World Hypertension Congress, Chennai
Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%
Certification bolsters Venus Remedies' position in PIC/S markets, reinforcing commitment to global quality standards
This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery
Lupin is set to become first Indian company to fully integrate Honeywell’s Solstice® Air in its respiratory inhalers at scale, redefining respiratory care with near-zero global warming potential propellants
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