FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD

T2Covered by 1 source · first reported by Fierce Biotech / Fierce Healthcare / MedCity / GEN at 02 Nov, 14:07 UTC

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…

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Sources

• T2FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCDFierce Biotech / Fierce Healthcare / MedCity / GEN02 Nov, 14:07