Enrollment Closed: What Moleculin’s MIRACLE Trial Teaches About AML Site Execution
Moleculin closed Part A enrollment at 89 subjects in its pivotal AML MIRACLE trial. Here's what site directors and...
The Brain-Wave Trial That Just Raised the Bar for Neuromodulation RCTs
A double-blind tACS trial targeting theta oscillations in methamphetamine patients sets a new design standard regulators will use to...
EDC Query Automation: Balancing Coverage With Site Capacity
EDC query automation improves data quality only when sites can respond without being overwhelmed by low-value queries.
Federal Agenda Lists Four Regulatory Changes for IRB Oversight
Federal government outlines four regulatory changes for IRB oversight affecting multisite studies, protocol reviews, and institutional compliance by 2027.
NewAmsterdam Pharma Starts Phase 2b Trial of Obicetrapib in Preclinical Alzheimer’s Disease
NewAmsterdam Pharma doses first participant in SPINOZA Phase 2b trial of obicetrapib for preclinical Alzheimer's disease, testing a CETP...
Iopofosine I 131 Shows 79% Major Response in BTK Inhibitor-Refractory Waldenström Macroglobulinemia
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
Vanda's tasimelteon meets Phase III endpoint in delayed sleep-wake disorder, advancing 60% of patients' sleep onset by 30+ minutes...
AbbVie’s Zumilokibart Meets Primary Endpoint in Phase 2 Atopic Dermatitis Study
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
Plinabulin earns FDA Fast Track Status for advanced NSCLC after ICI failure, advancing BeyondSpring's DUBLIN-4 Phase 3 trial in...
AB Science’s “Calendar Update” Is a GCP Inspection Disclosure in Disguise
AB Science buried a five-inspector "for cause" GCP inspection inside a financial calendar update. Masitinib's ALS trial and three...