FDA leadership said the agency will give greater weight to real‑world data in drug and device applications and is revisiting early‑phase trial reform to accelerate reliable evidence generation, remarks delivered by Commissioner Marty Makary to a Wall Street audience. The comments signal a push to modernize evidentiary standards and use large de‑identified datasets in regulatory decision‑making. Separately, the FDA moved quickly to expedite review of Johnson & Johnson’s Tecvayli plus Darzalex combination for multiple myeloma after positive data, illustrating the agency’s readiness to accelerate high‑impact oncology submissions. The rapid action underscores the FDA’s dual approach: broadening accepted data sources while preserving pathways for swift review when pivotal data are compelling. Companies should prepare for evolving dossier expectations that combine traditional randomized evidence with curated real‑world datasets and for potential speedier reviews when confirmatory outcomes are strong.