EDC query automation improves data quality only when sites can respond without being overwhelmed by low-value queries.

Federal government outlines four regulatory changes for IRB oversight affecting multisite studies, protocol reviews, and institutional compliance by 2027.

NewAmsterdam Pharma doses first participant in SPINOZA Phase 2b trial of obicetrapib for preclinical Alzheimer's disease, testing a CETP...

Iopofosine I 131 achieved 79% major response in BTK inhibitor-refractory Waldenström macroglobulinemia patients in Phase 2b trial data.

Vanda's tasimelteon meets Phase III endpoint in delayed sleep-wake disorder, advancing 60% of patients' sleep onset by 30+ minutes...

AbbVie's zumilokibart met all primary endpoints in Phase 2 atopic dermatitis testing, showing rapid skin and itch improvement with...

Plinabulin earns FDA Fast Track Status for advanced NSCLC after ICI failure, advancing BeyondSpring's DUBLIN-4 Phase 3 trial in...

AB Science buried a five-inspector "for cause" GCP inspection inside a financial calendar update. Masitinib's ALS trial and three...

AGENT framework achieves 100% mRNA bioactivity after 2+ months at 37°C, forcing a rethink of cold-chain assumptions in vaccine...

FDA Single IRB Rule for multisite trials advances to final rule status in December 2026, ending parallel IRB review...