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Bysanti (milsaperidone)

Updated ยทnext FDA decision on the calendar

Bysanti (milsaperidone) The FDA approved it on Feb 21, 2026. 2 FDA decisions on record below. Every date links its source.

VNDA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

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 · Feb 20, 2026 ✓ ApprovedVNDAPDUFA · Feb 21, 2026 ✓ ApprovedVNDA

Questions

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

No upcoming catalyst is on our calendar for Bysanti (milsaperidone); 2 FDA decisions are on record below.

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

On Feb 21, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Bysanti (milsaperidone) been approved by the FDA?

Yes. The FDA approved an application for Bysanti (milsaperidone) on Feb 21, 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.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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