What Radial’s 27-Site Brain Medicine Network Actually Means for EEG Endpoint Standardization
Radial's FDA-cleared Evoke EEG integration across 27 brain medicine clinics tests whether distributed neuroimaging endpoints can survive real-world site…
The Liquid Biopsy That Found Pancreatic Cancer Early Has a Bigger Regulatory Problem Than Its Science
PANXEON detects stage 1-2 pancreatic cancer with 87% sensitivity, but FDA's companion diagnostic pathway may be the bigger obstacle...
FDA Part 11 Compliance: Audit Trails and Electronic Signatures
FDA Part 11 Compliance requires validated systems, audit trails, and electronic signatures linked to individual users. Learn what triggers...
Phase III Clinical Trials Now Generate 5.9M Data Points Annually, Growing 11% Yearly
Phase III Clinical Trials now generate 5.9M data points annually with 11% yearly growth, raising questions about managing protocol...
Wearable neuromodulation reduces AF recurrence after ablation in pilot trial
Wearable neuromodulation reduces AF recurrence after ablation in pilot trial, with 90% freedom from arrhythmias at six months versus...
Accro Bioscience Doses First Patient in AC-101 Phase IIb Trial for Ulcerative Colitis
Accro Bioscience doses first patient in AC-101 Phase IIb trial for ulcerative colitis, targeting the NOD/RIPK2 pathway with a...
Antengene Starts Phase III CLINCH-3 Trial of ATG-022 in Advanced Gastric Cancer
Antengene launches Phase III CLINCH-3 Trial of ATG-022 in advanced gastric cancer, building on 46.7% response rates from Phase...
Lavengratinib Shows 100% Response Rate in Lowest Dose Achondroplasia Cohort
Lavengratinib achondroplasia trial shows 100% responder rate in lowest dose cohort with 2.4 cm/year growth improvement and clean safety...
When the Trial Fails, Was It the Drug or the Design?
NetraMark's Chief Innovation and Regulatory Officer Luca Pani, MD, on why broad enrollment can obscure treatment effects, what makes...
AbbVie’s Bet on Biology: Why One Modality Is Never Enough in Lung Cancer
Daejin Abidoye, Vice President, Therapeutic Area Head, Oncology, Solid Tumor and Hematology at AbbVie, discusses new data from ABBV-1480...