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pdufa.bio

FUROSCIX ReadyFlow

Updated ยทnext FDA decision on the calendar

FUROSCIX ReadyFlow is a MannKind Corporation program in Edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The FDA approved it on Jul 24, 2026. 1 FDA decision on record below. Every date links its source.

MNKD catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). Sponsor: MannKind Corporation (MNKD). Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Jul 24, 2026 ✓ ApprovedMNKDPDUFA · Jul 26, 2026MNKD

Questions

When is FUROSCIX ReadyFlow's next FDA decision or readout?

No upcoming catalyst is on our calendar for FUROSCIX ReadyFlow; 1 FDA decision is on record below.

What happened at FUROSCIX ReadyFlow's most recent FDA decision?

On Jul 24, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is FUROSCIX ReadyFlow used for?

In our records FUROSCIX ReadyFlow is under review or in development for Edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD).

Who makes FUROSCIX ReadyFlow?

MannKind Corporation (MNKD).

Has FUROSCIX ReadyFlow been approved by the FDA?

Yes. The FDA approved an application for FUROSCIX ReadyFlow on Jul 24, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.