In second reversal, FDA gives uniQure a green light to seek accelerated approval

June 17, 2026 11:40 AM EDT R&DCell/Gene TxFDA+ In an­oth­er re­ver­sal, FDA gives uniQure ac­cel­er­at­ed ap­proval path for Hunt­ing­ton's gene ther­a­py Max Gelman Senior Editor Reg­u­la­to­ry flex­i­bil­i­ty ap­pears to be back on the FDA’s menu fol­low­ing the de­par­tures of Mar­ty Makary and Vinay Prasad. … Sign up to read this article for free. Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox. SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER