Upadacitinib’s Phase 3 Vitiligo Data Just Redrew the Regulatory Map for JAK Inhibitors in Dermatology
AbbVie's Viti-Up trials showed upadacitinib 15mg hit F-VASI 75 in vitiligo across two Phase 3 studies—here's what the trial...
The AI Validation Gap: Decision Support Tools Are Outrunning Their Own Evidence
AI clinical trial decision support is a $1.35B market growing at 12.5% annually—but FDA's draft ML guidance and real-world...
LSD Just Beat Phase 3 Twice. Now Comes the Hard Part.
Definium's DT120 cleared Phase 3 in both MDD and GAD. As a ketamine PI who's treated 30,000+ patients, here's...
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...
AI Clinical Decision Support Is Everywhere. The Evidence Base Is Not.
71% of US hospitals now deploy predictive AI, but validation frameworks lag dangerously behind. Here's what that gap means...
The B-Cell Depletion Arms Race in CNS Autoimmune Trials Has a New Front-Runner — And It Rewrites the Regulatory Playbook
Obinutuzumab β's Phase 3 trial shows 93.1% relapse risk reduction in AQP4+ NMOSD, forcing a rethink of how rare...
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...
RiboX’s Circular RNA CAR-T IND Clearance Forces the Industry to Rethink Everything It Knows About Cell Therapy Trial Design
FDA cleared RiboX's RXIM002 IND for the first circular RNA-based in vivo CAR-T therapy — here's what it means...
The PTSD Nightmare Drug No One Expected: What Dronabinol’s RCT Tells Us About CNS Trial Design
A dronabinol RCT in Nature Medicine just outperformed prazosin's VA trial with 170+ PTSD patients. Here's what the trial...
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...