pdufa.bio

Bysanti (milsaperidone)

Updated ยทnext FDA decision on the calendar

Bysanti (milsaperidone) 1 FDA decision on record below. Every date links its source.

VNDA 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 · Feb 20, 2026 ✓ ApprovedVNDA

Questions

When is Bysanti (milsaperidone)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Bysanti (milsaperidone); 1 FDA decision is on record below.

What happened at Bysanti (milsaperidone)'s most recent FDA decision?

On Feb 20, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.