US biopharmaceutical company MannKind Corporation (NASDAQ: MNKD) announced on Friday that it has received US Food and Drug Administration approval for Furoscix ReadyFlow, a furosemide injection for adults with heart failure or chronic kidney disease experiencing edema.

The autoinjector delivers an IV-equivalent 80 mg/mL furosemide dose in under 10 seconds and is absorbed subcutaneously, with symptom relief potentially beginning within an hour. It is intended to support earlier outpatient intervention and reduce emergency visits, hospitalisation and readmission for worsening fluid overload.

Clinical data show Furoscix ReadyFlow met its primary pharmacokinetic endpoint and achieved equivalent urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours compared with IV furosemide. The therapy was generally well tolerated, with a safety profile consistent with oral and intravenous furosemide.

Heart failure affects about 6.7 million adults in the United States, rising to more than 8 million by 2030, and accounts for roughly 80% of related healthcare costs. Fluid overload is a major driver of worsening symptoms and hospital use, particularly when chronic kidney disease coexists.

The FDA-approved Furoscix delivered via an On-body infusor remains available following approvals for heart failure in 2022 and chronic kidney disease in 2025. Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026, reducing administration time from five hours with the infusor to 10 seconds or less.