pdufa.bio

Rybelsus (oral semaglutide)

Updated ยทnext FDA decision on the calendar

Rybelsus (oral semaglutide) 1 FDA decision on record below. Every date links its source.

NVO 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 · Oct 15, 2025 ✓ ApprovedNVO

Questions

When is Rybelsus (oral semaglutide)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Rybelsus (oral semaglutide); 1 FDA decision is on record below.

What happened at Rybelsus (oral semaglutide)'s most recent FDA decision?

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

Has Rybelsus (oral semaglutide) been approved by the FDA?

Yes. The FDA approved an application for Rybelsus (oral semaglutide) on Oct 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.