DANBURY, Conn., July 24, 2026. MannKind Corporation said the U.S. Food and Drug Administration has approved Furoscix ReadyFlow, an autoinjector version of its furosemide injection for edema in adults with chronic heart failure or chronic kidney disease. The company called it the first and only autoinjector capable of delivering subcutaneous furosemide with intravenous-equivalent exposure.

The device delivers a full 80 mg/mL dose of furosemide in under ten seconds. That compares with roughly five hours for MannKind’s existing Furoscix On-Body Infusor, which uses a wearable patch to deliver the same drug over an extended period. For patients managing recurring fluid overload from heart failure or chronic kidney disease, a same-day injection option could reduce the need for emergency room visits or IV diuretic infusions administered in a clinical setting.

Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026, MannKind said. The company filed the supplemental new drug application earlier this year after completing bridging studies intended to show the autoinjector produces comparable pharmacokinetics to the existing infusor.

Alongside the approval, MannKind announced a $50 million private placement to help fund the product launch and support broader commercial infrastructure. The financing underscores how much MannKind is leaning on Furoscix as a near-term commercial growth driver, distinct from its inhaled insulin franchise, Afrezza.

Heart failure remains one of the most expensive chronic conditions to manage in the U.S. healthcare system, in large part because of repeat hospitalizations tied to fluid overload. Diuretic therapy is the standard first-line treatment, but oral diuretics can lose effectiveness as kidney function declines, and IV diuretics typically require a hospital or infusion-center visit. An at-home injectable alternative that mimics IV-equivalent exposure gives physicians another option for patients who are stable enough to avoid a hospital stay but still need rapid, reliable diuresis.

Edema tied to heart failure and chronic kidney disease affects millions of patients in the United States, and payers have shown growing interest in therapies that can shift care out of expensive hospital settings without compromising outcomes. Analysts covering MannKind have flagged Furoscix’s site-of-care shift as the product’s central value proposition, since same-day, at-home dosing avoids the cost of an infusion center visit while giving physicians a tool to intervene before a patient’s condition worsens enough to require hospitalization.

MannKind’s approval adds to a run of FDA decisions this month across cardiometabolic and renal disease, as the agency continues to clear novel drug-device combinations designed to move complex therapies out of hospital and infusion-center settings and into patients’ homes.