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FDA extends Novo Nordisk's denecimig BLA review citing facility remediation, with no new action date set and a 2027 US launch still targeted.
FDA approves Eli Lilly's pirtobrutinib for first-line CLL/SLL, expanding the indication with new labeling warnings and orphan drug manufacturing obligations.
FDA revised HCT/P and non-blood biologics deviation reporting codes on Oct 1, 2026. QA teams must update submissions before the next reporting cycle.
FDA CBER revised blood product deviation codes effective October 1, 2026. QA teams must update deviation systems before next submission cycle.
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