The CHMP’s November Verdict: Seven Approvals, Eleven Extensions, and a Post-Approval Evidence Burden That Sponsors Underestimate
EMA's CHMP recommended 7 new medicines and 11 label extensions in November 2026, pushing its 2026 total to 79...
FDA Real-World Evidence
Your Trial’s Primary Endpoint Is Missing Half the Patient: What Deep Learning Gait Analysis Reveals About eClinical Data Strategy
A Nature Medicine deep learning model predicts 12+ multisystem health phenotypes from gait alone, exposing a critical blind spot...
The Libre Duo Authorization Signals a New FDA Posture on Dual-Biomarker Wearables: Who Benefits and Who Gets Left Behind
FDA's Libre Duo authorization on Aug 25 marks the first continuous ketone+glucose wearable cleared globally. Here's what it means...
The FDA Just Rewired Alzheimer’s Trial Design, Most Sponsors Haven’t Caught Up Yet
FDA's approval of two blood-based Alzheimer's tests signals regulators now accept plasma biomarkers as primary endpoints, reshaping CNS trial...
The Eye as a Biomarker: Why Retinal AI Could Reshape How Trials Screen and Stratify Pregnant Patients
A Nature Biotechnology retinal AI model detects preeclampsia and gestational hypertension risk non-invasively, and its trial implications go far...
The Pragmatic Trial Has Been Hijacked. Here Is What It Was Actually Supposed to Do.
JAMA's 2026 editorial exposes how "pragmatic trial" has been stretched beyond recognition, threatening regulatory credibility and real-world evidence quality.
The FDA Created an AI Office. Now Comes the Hard Part.
CDER's new Office of Innovation and Clinical Trial Modernization fuses AI and RWE policy under one roof. That structural...
The EPoS II Trial Just Made the 3-Year Colonoscopy Standard Look Like a Reflex, Not a Rule
EPoS II RCT finds 5-year colonoscopy surveillance noninferior to 3-year for high-risk adenoma patients, forcing a rethink of global...
Benchmark Scores Don’t Save Patients: Why Clinical AI Needs RCT-Grade Evidence Before It Touches a Workflow
Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...
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...