Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints

Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.

Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.

New PREDICT-DNA data suggests ultrasensitive ctDNA monitoring may outperform traditional markers in breast cancer relapse prediction. Read the full analysis.