Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine ...

A regulatory decision is expected during the first quarter of 2026. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for ...

Please provide your email address to receive an email when new articles are posted on . Second-line trastuzumab deruxtecan-nxki significantly improved outcomes for advanced gastric cancers compared ...

Trastuzumab deruxtecan is approved for HR-positive, HER2-low/ultralow metastatic breast cancer post-endocrine therapy, based on DESTINY-Breast06 trial results. The trial showed a 36% reduction in ...

Please provide your email address to receive an email when new articles are posted on . CHICAGO — Trastuzumab deruxtecan extended PFS compared with standard chemotherapy for certain patients with ...

Trastuzumab and T-DXd are effective in HER2-positive gastric and GEJ cancers, moving towards earlier intervention stages. A meta-analysis of T-DXd showed significant efficacy and manageable safety in ...

A Prescription Drug User Fee Act target date of May 18, 2026 has been set for the application. The sBLA submission was supported by data from the randomized, open-label, phase 3 DESTINY-Breast11 trial ...

Based on DESTINY-Breast06 Phase III trial results which showed ENHERTU demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year Approval brings ...

The approval is supported by data from the DESTINY-Gastric04 Phase III trial.

Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials Approximately one in five gastric cancers are HER2 positive.8,9 HER2 is a tyrosine kinase receptor growth promoting protein ...