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FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD

GEN — Genetic Engineering & Biotechnology News · Nov 2, 2026 — 14:07 · 0 views · Original article ↗

The FDA has delayed a decision on Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) seeking additional approval for mitapivat in sickle cell disease (SCD) until next year. The post FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD appeared first on GEN - Genetic Engineering and Biotechnology News .

The FDA has delayed a decision on Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) seeking additional approval for mitapivat in sickle cell disease (SCD) until next year. The post FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD appeared first on GEN - Genetic Engineering and Biotechnology News .

This is a summary of the story. Read the full article at GEN — Genetic Engineering & Biotechnology News ↗

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