Qureator announced that the FDA approved an Investigational New Drug (IND) application based solely on efficacy data generated with its vascularized tumor organoid model (vTIME), marking the first U.S. IND relying on human organoid efficacy in lieu of animal proof‑of‑concept studies under the FDA Modernization Act 2.0. The vTIME platform reproduced tumor vasculature and immune microenvironments and demonstrated synergy for BAL0891 plus checkpoint blockade; those human‑relevant results formed the pivotal evidence package for SillaJen’s IND amendment. Qureator said the decision reflects closer regulator‑industry collaboration and a shift toward predictive, human‑based preclinical models. If regulators increasingly accept organoid efficacy data, biotech yields could accelerate: companies may run faster, cheaper IND‑enabling programs using human models, reduce animal use, and improve translational fidelity. The industry will watch subsequent review cycles closely to see how broadly the precedent applies.