Vinay Prasad, director in FDA biologics, and agency commentary signaled a higher evidentiary bar for new CAR‑T approvals, arguing that novel cell therapies must demonstrate superiority over existing options. A journal article and subsequent industry commentary summarized the agency’s shift toward comparative outcomes rather than single-arm efficacy alone. BioCentury’s podcast flagged the regulatory shift alongside broader sector topics — M&A activity and the emergence of in‑vivo CAR‑T approaches — and discussed how heightened standards could reshape trial design, accelerate head‑to‑head comparisons, and increase the cost and timeline to approval for next‑generation cell therapies.