FDA maintains US hold on Hemopure, but non-US trials move ahead
This article was originally published in Clinica
Executive Summary
The US FDA has dealt a further blow to US blood substitute developer Biopure by maintaining the clinical hold on the IND application for its proposed RESUS phase II/III clinical trial of (Hemopure haemoglobin glutamer-250 (bovine)) for out-of-hospital treatment of trauma patients.