Qureator announced that the FDA approved an IND amendment for SillaJen’s combination therapy based solely on human vascularized organoid (vTIME) efficacy data — the first U.S. IND relying on organoid‑only efficacy under the FDA Modernization Act 2.0. The vTIME platform reproduced tumor vasculature and immune contexts and showed synergy between an anticancer drug and checkpoint blockade, which formed the basis for the regulatory filing. Separately, the FDA published a sponsors’ checklist to curb refuse‑to‑file delays, underscoring regulatory emphasis on robust dossier preparation and human‑relevant preclinical data. Together, these developments signal growing regulatory openness to non‑animal efficacy evidence and clearer guidance to minimize submission setbacks.