Orforglipron’s MACE Data Just Raised the Evidentiary Bar for Every Oral GLP-1 Program Behind It
Orforglipron's ACHIEVE-4 trial showed MACE-4 in 4.2% vs. 5.0% for insulin glargine, now every oral small-molecule GLP-1 program faces...
IQVIA Selects Veeva Clinical Operations Applications as Enterprise Standard Across Its Studies
IQVIA has made Veeva CTMS, eTMF, Study Startup and Site Connect enterprise standards across its clinical development studies, extending...
Wearable Devices Face Accuracy Gaps in Clinical Trial Endpoints
Wearable devices show accuracy gaps in clinical trial endpoints, with sleep stage detection varying significantly across consumer devices used...
Mabwell’s 9MW2821 Shows 30% Response Rate in ADC-Pretreated TNBC
Mabwell's 9MW2821 demonstrated a 30% response rate in ADC-pretreated triple-negative breast cancer patients, with an 8.7-month median duration of...
The CHMP’s October Scorecard: Six Approvals, Five Expansions, and What the Patterns Reveal About EMA’s Evolving Evidence Bar
EMA's CHMP recommended 6 new medicines and 5 label expansions in its Oct 12-15 cycle. Here's what daraxonrasib's pancreatic...
Fortrea Used Pre-Screening Logs to Fix Hypercholesterolemia Trial Enrollment
Fortrea rescued a Phase III hypercholesterolemia trial enrollment by using pre-screening logs and targeted site interventions to reduce screen...
Masimo smartSET gains FDA clearance for AFib and opioid depression detection
Masimo smartSET gains FDA clearance for AFib and opioid depression detection, adding AI-driven pattern recognition to pulse oximetry monitoring.
XS411 Parkinson’s cell therapy shows five hours daily ON-time gain in Phase I
XS411 Parkinson's cell therapy demonstrated five hours of daily ON-time gain in Phase I, with no serious adverse events...
Base Editing’s Decade of Promise Meets Its Regulatory Reckoning
Base editing reached human trials, but the FDA's April 2026 NGS safety draft guidance reveals how far the regulatory...
24/7 ICU Staffing Emerges as Key Factor in ARDS Trial Enrollment
24/7 ICU staffing emerges as critical factor in ARDS trial enrollment, with site selection now prioritizing round-the-clock research availability.