FDA’s April calendar includes remaining PDUFA decisions, including a pending call on an oncolytic virus and updates tied to delayed biologics. Replimune’s oncolytic virus Vusolimogen oderparepvec (REPL) remains in focus, after an Orca Biosystems delay shifted Treg cell therapy Orca-T to July. The “PDUFA dates remaining” framing highlights how the FDA’s Center for Biologics Evaluation and Research is continuing to manage review timelines across multiple platform types—oncolytic viruses and advanced cell therapies. For developers, the key operational takeaway is that CMC and clinical data packages continue to drive whether decisions move forward as scheduled or slip—directly influencing funding, partnering, and commercial readiness plans.