The Oversight Gap Nobody Is Naming: State Sandboxes Are Filling a Void the FDA Has Left Open
Utah's clinical AI sandbox and the FDA's 1,451 AI device authorizations reveal a structural oversight gap—states are building what...
Aktis Oncology’s AKY-2519 Shows Lower Salivary Gland Toxicity in First-in-Human Study
Aktis Oncology's AKY-2519 demonstrates lower salivary gland toxicity compared to approved PSMA agents in first-in-human dosimetry study.
TaiMed Completes Phase 2b Enrollment for TMB-365/380 HIV Therapy
TaiMed completes Phase 2b enrollment for TMB-365/380, a dual antibody HIV therapy dosed every two months without pre-screening requirements.
Tedopi Plus Pembrolizumab Improves Progression-Free Survival in Ovarian Cancer
Tedopi Plus Pembrolizumab reduces progression or death risk by 47% versus supportive care in platinum-sensitive recurrent ovarian cancer.
Hansa Biopharma’s Idefirix shows 90% graft survival in kidney transplant study
Idefirix kidney transplant study reports 90% graft survival at one year in highly sensitized patients, supporting Hansa's bid for...
Novartis Presents 2.5-Year IgAN Kidney Function Data for Atrasentan
Novartis presents 2.5-year kidney function data for atrasentan in IgA nephropathy, evaluating durable eGFR preservation beyond proteinuria reduction.
BIIB122 Fails to Slow Motor Progression in Phase 2b Parkinson’s Study
BIIB122 fails to slow motor progression in Phase 2b Parkinson's study despite strong target engagement in 648 patients.
The Coordinator Crunch Is Costing You Patients — Not Just Morale
Coordinator burnout drives enrollment collapse. Here's the operational math sponsors miss—and what sites need from Monday morning.
Rogaratinib’s 41.7% Response Rate in SDH-Deficient GIST Rewrites the Playbook for Epigenetically Driven Trial Design
A 24-patient Phase 2 trial of rogaratinib hit 41.7% partial response in SDH-deficient GIST—a tumor that imatinib cures just...
The FDA Said No. Europe Said Yes. Someone Is Wrong About Camizestrant.
AstraZeneca's Etcamah won EMA approval weeks after FDA adcom rejection—exposing a regulatory split that demands answers on endpoint standards...