08.11.2026
FDA Accepts Belite Bio’s NDA for Tinlarebant in Stargardt Disease
The FDA has accepted Belite Bio’s new drug application (NDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1) and granted the application Priority Review, the company announced. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027.