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Utebzi (Tebipenem HBr)

Updated ยทnext FDA decision on the calendar

Utebzi (Tebipenem HBr) 2 FDA decisions on record below. Every date links its source.

GSK catalyst hub · SPRO catalyst hub

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 · Jun 17, 2026 ✓ ApprovedGSKPDUFA · Jun 17, 2026 ✓ ApprovedSPRO

Questions

When is Utebzi (Tebipenem HBr)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Utebzi (Tebipenem HBr); 2 FDA decisions are on record below.

What happened at Utebzi (Tebipenem HBr)'s most recent FDA decision?

On Jun 17, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.