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Mar 02, 2026
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
Feb 24, 2026
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
Feb 17, 2026
New clinical trial data show trastuzumab deruxtecan plus pertuzumab extends progression-free survival as first-line therapy, while MRI-guided treatment shortening reduces toxicity in neoadjuvant settings for HER2-positive breast cancer.
Feb 20, 2026
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
Feb 15, 2026
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Feb 15, 2026
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
Feb 14, 2026
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
Feb 14, 2026
Charles River Laboratories is scheduled to report Q4 2025 results on Feb. 18, with analysts raising price targets while the company navigates biotech funding pressures and announces new gene therapy collaborations.
Feb 14, 2026
Alphamab Oncology has dosed the first patient in a Phase III study of JSKN003, a biparatopic HER2-targeting ADC, for HER2-positive advanced colorectal cancer. The drug demonstrated a 68.8% response rate in earlier trials.
Feb 13, 2026
Innovent Biologics has dosed the first participant in its pivotal Phase 3 HeriCare-Breast01 study evaluating IBI354, a HER2-targeted antibody-drug conjugate, as first-line treatment for unresectable locally advanced or metastatic HER2-positive breast cancer.
