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 23, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD) (approved Jul 23, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: MannKind Corporation (MNKD). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 0 upcoming and 1 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.
No upcoming catalyst is on our calendar for FUROSCIX ReadyFlow; 1 FDA decision is on record below.
On Jul 24, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records FUROSCIX ReadyFlow is FDA-approved for edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD) (approved Jul 23, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
MannKind Corporation (MNKD).
Yes. The FDA approved an application for FUROSCIX ReadyFlow on Jul 24, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.