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2026 Predictions: Historic FDA Shift, Plausible Mechanisms, Bespoke Tx, RFK Jr., Biotechs, State AGs, Peptides, Embryos

The blog forecasts a historic regulatory shift in 2026, with the FDA likely approving Capricor’s deramiocel for Duchenne muscular dystrophy and at least two additional cell therapies based on limited data. New FDA buzzwords—plausible mechanisms, N=1 trials, bespoke therapies, and real‑world evidence—are expected to drive faster approvals, even as the agency continues issuing warning letters. RFK Jr. may push for looser peptide regulations, creating a dual environment of easier compounding and heightened safety incidents. State legislatures and aggressive AG actions will further test the balance between federal oversight and local stem‑cell markets.