Regulatory Updates

ASCENT-03: Trodelvy Plus Pembrolizumab Demonstrates Significant PFS Benefit in First-Line Metastatic Triple-Negative Breast Cancer

ASCENT-03 trial shows Trodelvy plus pembrolizumab significantly improved PFS vs chemo plus pembrolizumab in first-line mTNBC patients.

FDA approves lurbinectedin plus atezolizumab for ES-SCLC maintenance, extending OS to 13.2 months vs 10.6...

FDA grants Priority Review for Enhertu plus pertuzumab in first-line HER2+ metastatic breast cancer, with...

FDA approves gemcitabine intravesical system for BCG-unresponsive bladder cancer, showing 82% complete response rate in...

Modeyso, the first treatment option for this ultra-rare and aggressive brain tumor, is commercially available...

Verzenio plus endocrine therapy offers statistically significant OS improvements over endocrine therapy alone in high-risk...

The FDA has issued a Complete Response Letter for TLX250-CDx (Zircaix), rejecting the biologics license...

FDA expands Pluvicto for earlier use while PARP inhibitors show benefit in BRCA1/2+ patients, advancing...

Zongertinib becomes first oral HER2-targeted therapy for NSCLC, achieving 75% response rate in previously treated...

FDA grants de novo authorization to ArteraAI Prostate, first AI tool to prognosticate long-term outcomes...

FDA grants Breakthrough Therapy Designation to izalontamab brengitecan for previously treated EGFR-mutated NSCLC patients.