pdufa.bio

Afrezza (Technosphere Insulin)

Updated ยทnext FDA decision on the calendar

Afrezza (Technosphere Insulin) 1 FDA decision on record below. Every date links its source.

MNKD catalyst hub

About this program

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.

Catalyst history

PDUFA · May 29, 2026 ✓ ApprovedMNKD

Questions

When is Afrezza (Technosphere Insulin)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Afrezza (Technosphere Insulin); 1 FDA decision is on record below.

What happened at Afrezza (Technosphere Insulin)'s most recent FDA decision?

On May 29, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.