# FDA Wants Orca Bio's Cancer Therapy. Fix the Factory.

- slug: fda-wants-orca-bios-cancer-therapy-fix-the-factory
- date: 2026-04-02
- category: Biotech & Life Sciences

The FDA hit Orca Bio with a 3-month manufacturing delay — not a safety problem. The Phase 3 data remains striking: 78% of transplant patients alive without severe chronic GVHD at one year, versus 38.4% on the standard regimen.

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