Vaxcyte’s VAX-31 Advances With Three Phase 3 Trials Enrolling 6,191 Adults
Vaxcyte's VAX-31 Phase 3 trials enroll 6,191 adults across three fully enrolled studies designed to challenge Prevnar 20 and...
Daraxonrasib Doubles Overall Survival in Second-Line Pancreatic Cancer
Daraxonrasib doubled overall survival in second-line metastatic pancreatic cancer versus chemotherapy in the RASolute 302 trial.
SPARK Just Ran 5,400-Patient Oncology Research Autonomously. Your Trial’s Biomarker Strategy Has Not Caught Up.
SPARK agentic AI validated prognostic biomarkers across 5,400 patients and 18 cancer types—here's what that means for trial enrichment...
The FY2024 BIMO Report Confirms It: Sponsor Oversight Failures Are Now Structural
FDA's FY2024 Bioresearch Monitoring report shows 25% of sponsor inspections drew a Form 483, with the same recurring findings...
Aktis Oncology Initiates Phase 1b Trial of AKY-2519 in mCRPC
Aktis Oncology initiates Phase 1b trial of AKY-2519 in metastatic castration-resistant prostate cancer, targeting B7-H3 expression.
When Gilead Cuts 108 Jobs at Arcellx, Your Trial Feels It Before You Know Why
Gilead's $7.8B Arcellx acquisition just cut 108 Redwood City jobs. Here's what that means for CAR-T trial sites running...
Zentalis Launches ASPENOVA Phase 3 Trial of Azenosertib in Platinum-Resistant Ovarian Cancer
Zentalis launches ASPENOVA Phase 3 trial of azenosertib in platinum-resistant ovarian cancer, targeting Cyclin E1-overexpressing tumors with a dual-track...
Dupixent Improves Esophageal Function in Phase 4 Eosinophilic Esophagitis Trial
Dupixent improves esophageal function in Phase 4 trial, achieving structural changes equivalent to dilation procedures without mechanical intervention.
6.4 Million Patients Can’t Be Wrong — But Can Regulators Read What This Validation Is Actually Saying?
A Nature Medicine validation of PREVENT and SCORE2 across 6.4M individuals offers a blueprint for RWE methodology that FDA...
Cellectar’s Iopofosine Meets FDA Durability Requirements in Waldenström Study
Cellectar's iopofosine meets FDA durability requirements in Waldenström study with 83.6% ORR and 17.8-month median response duration.