Ony Infasurf Claims Dinged By FDA After Firm Challenges Rival’s Study
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA sent an untitled letter to Ony objecting to web pages and “blurry” video text that imply its lung surfactant is superior to competing products and minimizes Infasurf’s risks; Ony sued Cornerstone last year over its superiority claims.