The MASAI Trial Just Made AI-Augmented Mammography the Standard of Care. The FDA Hasn’t Noticed
The MASAI trial showed AI-plus-one-radiologist outperforms two radiologists in breast cancer screening. FDA's AI device framework still treats this...
Adaptive Trial Design
The Basket Trial Is the New Black — and the FDA Hasn’t Caught Up
Arrowhead Pharmaceuticals' Phase 1 basket trial of zodasiran enrolled five distinct lipid disorder populations under a single protocol —...
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...