MannKind wins FDA approval for 80 mg Furoscix

• The FDA approved MannKind’s Furoscix ReadyFlow autoinjector for edema linked to heart failure or chronic kidney disease.
• MannKind shares were up 1.4% at $3.89 following the announcement.
• The company expects to launch the treatment in the United States by the end of August 2026.

MannKind (NASDAQ:MNKD) received FDA approval for Furoscix ReadyFlow, an 80 mg/mL autoinjector treating edema in adults with heart or kidney disease.

The device delivers subcutaneous furosemide in under 10 seconds, compared with approximately five hours using the existing on-body infusor.

Clinical testing showed 107.3% bioavailability and similar urine, sodium and potassium output versus intravenous furosemide at six, eight and 12 hours.

MannKind said the safety profile matched established furosemide use, while the product targets cardiologists, nephrologists and outpatient heart-failure clinics.

MannKind expects a U.S. launch by late August.

The Furoscix on-body infusor received adult heart-failure approval in 2022, kidney-disease approval in 2025 and a pediatric expansion in December 2025.