The Liver Signal Europe Just Sent About Cenobamate Will Reshape How Sponsors Design Post-Approval Safety Plans
The EMA's PRAC issued a direct communication to healthcare professionals about severe liver injury linked to cenobamate in April...
Clinical Trial Design
France Approved IV Ketamine for Suicidal Crisis. The FDA Should Be Uncomfortable Right Now.
France's March 2026 authorization of intravenous racemic ketamine for acute suicidal crisis is the first regulatory approval of its...
The GLP-1 Pill Just Broke Every Obesity Trial Playbook
The FDA's approval of oral orforglipron for obesity isn't just a formulation win — it's a structural disruption to...
The EMA’s Virtual Control Group Gambit Could Redraw the Map for Pivotal Trial Design
The EMA has opened consultation on a draft qualification opinion for virtual control groups — a methodology that, if...
The POLAR Trial Proves Pancreatic Cancer Trials Were Broken by Design
The POLAR trial's Phase 2 results in homologous-recombination-deficient metastatic pancreatic cancer aren't just a clinical win — they're an...
One Biomarker, Two Diseases: The p-tau Signal That Just Complicated Your Stratification Strategy
A multicenter cross-sectional study in Nature Medicine shows serum p-tau—the cornerstone of Alzheimer's blood-based diagnostics—may also detect systemic amyloidoses....
Triplet Regimen, Biomarker Gate, Phase 3 Signal: What ILUSTRO’s Cohort 4 Actually Proves
Astellas's ILUSTRO trial just published Phase 2 data showing a zolbetuximab-nivolumab-mFOLFOX6 triplet in CLDN18.2-positive gastric cancer produces response rates...
How a Single eGFR Change Is Exposing the Clinical Trial Industry’s Embedded Patient Bias Problem
A new real-world evidence study shows that removing race from the kidney function algorithm resulted in 5.3 more transplants...