Proteomic Aging Clocks Just Changed What a Phase 2a Trial Has to Prove
A Nature Biotechnology phase 2a trial ran six proteomic aging clocks simultaneously, here's what that means for biomarker strategy...
Kylo-11’s 97% Lp(a) Reduction from a Single Dose Rewrites the Durability Standard for siRNA Cardiovascular Trials
A single 600 mg dose of Kylo-11 cut lipoprotein(a) by 97% at 48 weeks in a Phase 1 trial,...
Lecanemab’s At-Home Start Dose Just Rewrote the Rules for Alzheimer’s Trial Design
FDA's July 2026 approval of at-home subcutaneous lecanemab initiation eliminates the 18-month IV requirement, reshaping CNS trial recruitment and...
Rapid Whole-Genome Sequencing Is Leaving the Research Ward and Entering the PICU Protocol — What Sponsors Need to Watch
Nature Medicine's citywide Dubai rWGS study and Seattle Children's 1,000-patient rollout signal a regulatory inflection point for genomic diagnostics...
iPSC Cardiomyocytes Reach the Beating Heart: What This Trial Design Tells Sponsors About the Next Frontier of Cell Therapy Protocols
A Nature Medicine RCT of allogeneic iPSC-derived cardiomyocytes in advanced ischemic heart failure just set the protocol bar for...
AI Clinical Decision Support Is Outrunning Its Own Evidence Base: What Trial Operators Need to Know Now
71% of U.S. hospitals now run predictive AI in their EHRs, but a 9,600-patient Kenya trial shows improved clinician...
Nature Medicine Just Published the AI Mental Health Audit Framework the FDA Hasn’t Written Yet
Nature Medicine's clinically validated AI chatbot audit framework arrives as FDA still lacks generative AI mental health approval standards—here's...
LITMUS Changes the Biopsy Calculus: What the Nature Medicine Data Means for Your MASLD Protocol
A Nature Medicine study using the 10,000-patient LITMUS registry shows non-invasive fibrosis tests can replace liver biopsy endpoints. Here's...
Latigo’s LTG-001 Phase 2b Data Signals a New Design Standard for NaV1.8 Pain Trials
Latigo Biotherapeutics' LTG-001 hit SPID48 in 343 patients, published in NEJM — here's what the trial design tells regulators...
The LITMUS Study Just Changed How You Should Design Your MASLD Trial Endpoints
LITMUS Imaging Study validates imaging and serum biomarkers for MASLD fibrosis—here's what it means for endpoint strategy in your...