Disconnected systems hinder RBQM adoption in clinical trials, FDA compliance
Only 57% of clinical trial organizations have adopted risk-based quality management, with disconnected systems creating regulatory compliance gaps for...
Niia Signature Patch Shows 20-Minute Glucose Signal Recovery After Insulin Bolus
Niia Signature Patch achieves 20-minute glucose signal recovery after insulin bolus, addressing a key challenge in all-in-one diabetes patches.
Giredestrant Plus Everolimus Just Cleared the Bar: What the evERA Data Actually Demands From Trial Designers
NEJM publishes evERA Breast Cancer trial data showing giredestrant plus everolimus superiority in HR+ advanced breast cancer, here's what...
DHHS Releases 2026 Unified Agenda With Five Clinical Research Rule Changes
DHHS 2026 Unified Agenda proposes five clinical research rule changes affecting Phase 1 INDs, single IRB requirements, and human...
Mineralys to Present Lorundrostat Phase 3 Data at ASN Kidney Week 2026
Mineralys presents Lorundrostat Phase 3 results from the Launch-HTN trial at ASN Kidney Week 2026, testing efficacy in treatment-resistant...
Teva Presents Post Hoc Ecopipam Data Ahead of 2027 FDA Decision
Teva presents post hoc ecopipam data for pediatric Tourette syndrome ahead of the FDA's Q1 2027 decision, identifying patient...
FDA extends denecimig review timeline, no decision date set
FDA extends denecimig review with no target decision date set. Novo Nordisk's haemophilia A therapy remains under evaluation beyond...
Three regulatory guidelines converge on risk-based quality management for clinical trials
ICH E6(R3), E8(R1), and MHRA guidance now align on risk-based quality management for clinical trials, requiring sponsors to update...
FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors
FDA's AI Risk-Based Guidance shifts validation burden to sponsors, requiring documented credibility assessments before deploying AI in clinical trials.
Lundbeck presents MSA trial baseline data, Lu AF28996 Phase Ib results at MDS 2026
Lundbeck presents baseline enrollment data from Phase III MASCOT trial of amlenetug for multiple system atrophy, with efficacy results...