The FDA issued a complete response letter to Incyte, blocking a label expansion for the company’s monoclonal antibody product due to problems at a third‑party manufacturing site in Indiana formerly owned by Catalent. The CRL underscores persistent regulatory risk tied to outsourced biologics manufacturing and may delay Incyte’s commercialization plans. Companies relying on external CMOs face heightened scrutiny; sponsors must demonstrate robust quality oversight and remediation plans before regulatory acceptance of expanded indications.