Rhythm Pharmaceuticals announced expanded Phase 3 TRANSCEND trial data showing an 18.8% placebo-adjusted BMI reduction at 52 weeks for setmelanotide in acquired hypothalamic obesity, with FDA PDUFA goal date set for March 20, 2026.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
