MannKind Corporation (MNKD) Secures FDA Approval for FUROSCIX Pediatric Use, Expanding Reach In Heart, Kidney Disease Care

MannKind Corporation (NASDAQ:MNKD) is one of the best NASDAQ stocks to buy in 2026. On December 23, MannKind Corporation secured FDA approval for the FUROSCIX On-body Infusor to treat pediatric patients weighing 43 kg or more. This expands the treatment’s existing reach beyond adults with chronic heart failure/CHF and chronic kidney disease/CKD, providing a home-based option for managing fluid buildup/edema.

Earlier on December 1, MannKind Corporation (NASDAQ:MNKD) announced that the US FDA accepted for review a Supplemental NDA for the FUROSCIX ReadyFlow Autoinjector (SCP-111). This device is designed to treat edema in adults suffering from CHF or CKD. The FDA set a Prescription Drug User Fee Act/PDUFA target action date of July 26, 2026, to decide on the application.

The ReadyFlow Autoinjector would deliver an IV-equivalent dose of 80 mg/ml subcutaneous furosemide in under 10 seconds. This represents a shift in administration time compared to the currently approved FUROSCIX On-body Infusor, which takes 5 hours to deliver the medication. The On-body Infusor was previously approved for CHF in 2022 and for CKD in 2025. The new autoinjector aims to provide a faster, more convenient, and cost-effective home-based option for managing fluid buildup, potentially reducing hospital admissions.

MannKind Corporation (NASDAQ:MNKD) is a biopharmaceutical company that develops and commercializes therapeutic products and services for endocrine and orphan lung diseases in the US.

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Disclosure: None. This article is originally published at Insider Monkey.