Apalutamide Cuts Metastasis Risk 20% in Prostate Cancer Surgery Trial
Apalutamide reduced metastasis risk by 20% in the Phase 3 PROTEUS trial of prostate cancer surgery patients with high-risk...
FDA Accepts NDA for Roche’s Giredestrant in Early-Stage Breast Cancer
FDA accepts Roche's giredestrant NDA for early-stage breast cancer with 30% reduction in recurrence or death in phase III...
When AI Picks Your Site, Execution Still Happens in the Building
ASCO and Ryght AI are using machine learning to select breast cancer trial sites. Here's what that means for...
The Trial Architecture Neurodegenerative Disease Has Always Needed — And Kept Refusing to Build
MAMS platform trials could end neurology's 99.6% drug failure rate. The Lancet just made the case. Here's what the...
Psychedelic Trials Are Effectively Open-Label. The FDA Has to Decide What to Do With That.
A meta-analysis of 112 psychedelic RCTs found >90% unblinding rates, meaning every efficacy estimate in the field may be...
Decentralized Trials Are Everywhere. Nobody Agrees What They’re For.
DCTs promise faster enrollment and broader diversity, but sponsors, CROs, sites, and regulators each want something different—and the TELEPIK...
Twelve Months, Three Patients: The Enrollment Crisis No Algorithm Can Fix
Sponsors poured $3B into AI to fix trial enrollment and 80% still miss deadlines. Three clinical-ops voices on why...
Eli Lilly’s Five-Day Ultimatum: How Pharma Is Weaponizing 340B Deadlines to Squeeze Hospital Trial Networks
Eli Lilly gave 1,000+ hospitals five days to submit claims data or lose 340B discounts—exposing how pharma giants shift...
Iopofosine I-131 Shows 79% Response Rate in BTKi-Resistant Waldenström Macroglobulinemia
Iopofosine I-131 achieves 79% response rate in BTKi-resistant Waldenström Macroglobulinemia patients, with median response duration of 16 months.
Voyager Gets FDA Clearance for VY1706 Gene Therapy Targeting Tau in Alzheimer’s
Voyager's VY1706 gene therapy targeting tau protein receives FDA clearance, with first-in-human dosing expected in late 2026 for early...