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...
Akeso’s Ivonescimab OS Data From HARMONi-6 Selected for ASCO Plenary
Akeso's ivonescimab OS data from HARMONi-6 heads to ASCO plenary as a head-to-head Phase III trial against tislelizumab in...
TaiMed’s TMB-365/380 HIV Study Completes Phase 2b Enrollment Early
TaiMed's TMB-365/380 HIV Study completes Phase 2b enrollment ahead of schedule with viral suppression data matching expectations after two...
The Cancer Nobody Saw Coming: What One Gene Therapy Tumor Tells Us About a Broken Safety Surveillance System
A rare gene therapy-linked cancer case exposes fatal gaps in long-term safety monitoring—and why FDA's 15-year follow-up mandate isn't...
Infex’s RESP-X shows reduced exacerbations in Phase IIa bronchiectasis trial
RESP-X shows reduced exacerbations in Phase IIa bronchiectasis trial, with 100% target coverage and lung penetration confirmed.