EMA’s PRAC October 2026 Review of Deanxit Signals Tightened Scrutiny on Fixed-Dose CNS Combination Products
EMA's PRAC launched a Deanxit safety review on Oct 16, 2026, citing serious neurological and psychiatric adverse events, here's...
ICON’s FIRECREST Platform Cuts Video Production Time by 90% With New AI Engine
ICON's AI-directed video engine cuts clinical trial video production time by 90%, streamlining site selection and training across 500,000+...
Citius Oncology Presents LYMPHIR Quality-of-Life Data at EORTC Meeting
Citius Oncology presents LYMPHIR quality-of-life data from pivotal Study 302 at EORTC meeting, supporting formulary discussions with European payers.
ATG-201 Phase I trial opens in China for B cell autoimmune diseases
ATG-201 Phase I trial opens in China for B cell autoimmune diseases, testing a CD19×CD3 bispecific with masking technology...
Eton’s ET-700 shows better tolerability than GALZIN but reduced efficacy in Wilson disease pilot
Eton's ET-700 shows better tolerability than GALZIN but reduced efficacy in Wilson disease pilot study with 12 patients per...
Ivonescimab Achieves 50.7% pCR Rate in Phase II Perioperative NSCLC Study
Ivonescimab perioperative NSCLC study shows 50.7% pathological complete response rate, outpacing current standard-of-care pembrolizumab regimens in early-stage
Brii Bio’s BRII-179 Shows 32% HBsAg Loss Durability in Hepatitis B Study
BRII-179 showed 32% HBsAg loss durability at 24 weeks post-treatment in the Phase 2b ENRICH study, with consistent results...
Diversity Planning Belongs in Protocol Design, Not the Enrollment Crisis Meeting
A new pilot shows early diversity planning cuts mid-trial amendments, here's what that means for site selection, IRT setup,...
MASH Trials Are Screening Out the Patients They Were Designed to Treat
MASH trial NIT thresholds misalign with clinical practice, creating screen failure crises that delay approvals and exclude the patients...
Clinical Research Sites Report Growing Trial Complexity Strain
Clinical research sites report trial complexity as their top operational problem, with 41% naming it their biggest challenge as...