PDS Biotechnology Halts PDS0101 Trial, Pivots to PDS0301 in Colorectal Cancer
PDS Biotechnology halts PDS0101 trial in head and neck cancer to redirect resources toward PDS0301 development in colorectal cancer.
AI Is Clearing Phase I. That’s the Wrong Finish Line.
Of 117 AI-enabled drug assets tracked in clinical trials, only 8 have cleared Phase II. Speed is real. Efficacy...
Scholar Rock’s Apitegromab Filing Exposes the CMO Due Diligence Gap That Keeps Burning Sponsors
Scholar Rock dropped Novo's Catalent plant from its SMA drug refiling after an OAI inspection. The compliance rot was...
The B-Cell Depletion Arms Race in CNS Autoimmune Trials Has a New Front-Runner — And It Rewrites the Regulatory Playbook
Obinutuzumab β's Phase 3 trial shows 93.1% relapse risk reduction in AQP4+ NMOSD, forcing a rethink of how rare...
Sionna’s SION-719 Misses Sweat Chloride Target in CF Study
Sionna's SION-719 fails to meet sweat chloride target in Phase 2a CF study of patients already on Trikafta therapy.
Oncoinvent publishes dosimetry data for Radspherin in peritoneal metastases
Oncoinvent publishes dosimetry data for Radspherin showing normal organ doses below complication thresholds in peritoneal metastases patients.
Tenax Announces Phase 3 LEVEL Trial Topline Results for TNX-103 in PH-HFpEF
Tenax announces Phase 3 LEVEL Trial topline results for TNX-103 in pulmonary hypertension with heart failure, a challenging indication...
Kodiak Sciences Enrolls First Patient in Phase 3 ALTO Trial of KSI-501 for Diabetic Macular Edema
Kodiak Sciences enrolls first patient in Phase 3 ALTO trial of KSI-501, testing dual IL-6 and VEGF blockade in...
The ICON-Anthropic Deal Will Reach Your Site Before You’re Ready for It
ICON's multi-year Claude deployment will reshape eTMF workflows, protocol timelines, and site data ops. Here's what coordinators need to...
Nature Medicine Just Published the AI Mental Health Audit Framework the FDA Hasn’t Written Yet
Nature Medicine's clinically validated AI chatbot audit framework arrives as FDA still lacks generative AI mental health approval standards—here's...