Orca Bio – FDA Extends Orca-T Review Timeline

Summary The FDA has extended the review timeline for Orca Bio’s biologics license application (BLA) for Orca-T, a high-precision allogeneic cell therapy for hematologic malignancies. The updated PDUFA date has been moved from April 6, 2026 to July 6, 2026 following submission of additional CMC-related…