FDA rejects Novartis AHF drug serelaxin; more efficacy evidence needed
This article was originally published in Scrip
Executive Summary
Novartis revealed early on 16 May the FDA has rejected the company's biologic license application (BLA) for its experimental acute heart failure (AHF) drug serelaxin, also known as RLX030, declaring more evidence on the drug's efficacy was needed for US licensure.