MannKind Corporation has announced that the FDA has accepted the sNDA seeking approval for the FUROSCIX ReadyFlow Autoinjector, which would deliver a subcutaneous furosemide injection in under 10 seconds. If approved, this device could provide a cost-effective and convenient option for patients with chronic heart failure or chronic kidney disease to manage fluid buildup episodes at home. The PDUFA target action date is set for July 26, 2026. The ReadyFlow Autoinjector aims to reduce administration time from five hours to under 10 seconds, offering faster relief and potentially lowering healthcare costs.

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