The new regimen, delivering 50 mg/5 mL and 28 mg/5 mL doses, offers a higher concentration of the drug for both loading and maintenance phases
Lonza will take on technology transfer, process optimization, and cGMP manufacturing, leveraging its global network and expertise in highly potent compounds
The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors
The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN
The decision is based on the phase 3 DESTINY-Breast11 trial
The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework
The approval covers pediatric patients without a matched sibling donor for stem cell transplant
Since launching, the hospital has performed over 40 intestinal transplants, including 21 in 2025 alone
As Tracky launches integrated health solution
The collaboration will see HNL Lab Medicine deploy Ibex’s cutting-edge AI solution, Ibex Prostate, for biopsies and transurethral resection of the prostate (TURP), boosting both diagnostic accuracy and workflow efficiency
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