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FDA accepts Rezzayo supplemental NDA for priority review

CorMedix announced FDA acceptance of its supplemental new drug application for Rezzayo (rezafungin) for priority review for prophylaxis of invasive fungal diseases.

CRMD

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11:35:28 AM UTC
SquawkNews
CorMedix said the FDA accepted and granted Priority Review to the sNDA for REZZAYO for prophylaxis of invasive fungal disease, with a PDUFA target action date in Q1 2027.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory step advancing REZZAYO from treatment-only use toward a proph…