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.

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

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.