clinicaltrialvanguardOpinion

AI Is Flooding Drug Discovery With Candidates. Clinical Validation Has No Flood Gates.

AI can generate 100x more drug candidates, but trials still need real patients. The bottleneck has shifted, and most sponsors ...
clinicaltrialvanguardOpinion

The Dystrophin Standard: How a 1% Biomarker Signal Became a $967 Million Accelerated Approval Precedent

FDA granted four DMD antisense oligonucleotide accelerated approvals on ~1 percentage-point dystrophin increases. With $967M ...
clinicaltrialvanguard

Icotrokinra’s NEJM Data Reveals the Quiet Shift in How UC Trials Get Designed and Approved

J&J's icotrokinra hit every UC endpoint in NEJM's Oct 2026 data, and the trial design choices behind that success are ...
clinicaltrialvanguard

FDA Clears Haemonetics PerQseal Elite Vascular Closure System

FDA clears Haemonetics PerQseal Elite vascular closure system for large-bore arterial procedures, showing zero major ...