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
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
The X CUBE 50 integrates ALPINION’s advanced X+ Architecture
The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub
The move is expected to be crucial during health crises
The cleared system pairs a flexible nitinol implant with a deployable prong-locking mechanism, delivering rotational and length stability
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
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