Drug Approval | November 21, 2025
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in invasive disease-free survival
Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma
The modular platform not only targets solid tumors but could also enhance traditional autologous and in vivo T cell therapies
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events
OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue
The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line
While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage
Relmada expects to initiate its Phase 3 program in the first half of 2026
Subscribe To Our Newsletter & Stay Updated
