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pdufa.bio

Semaglutide

Updated ยทnext FDA decision on the calendar

Semaglutide is a Novo Nordisk A/S program. Its next catalyst is a Readout in Dec 2026. 1 FDA decision on record below. Every date links its source.

NVO catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Semaglutide is marketed as Wegovy (semaglutide); the events below include those tracked under the brand name. Sponsor: Novo Nordisk A/S (NVO). We track 3 catalyst events for this program: 1 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 · Aug 15, 2025 ✓ ApprovedNVOReadout · Aug 2026NVOReadout · Dec 2026NVO

Questions

When is Semaglutide's next FDA decision or readout?

The next tracked catalyst for Semaglutide is a Readout in Dec 2026.

What happened at Semaglutide's most recent FDA decision?

On Aug 15, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Semaglutide?

Novo Nordisk A/S (NVO).

Has Semaglutide been approved by the FDA?

Yes. The FDA approved an application for Semaglutide on Aug 15, 2025; 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.