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INLEXZO (gemcitabine intravesical system)

Updated ยทnext FDA decision on the calendar

INLEXZO (gemcitabine intravesical system) 1 FDA decision on record below. Every date links its source.

JNJ 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 · Sep 9, 2025 ✓ ApprovedJNJ

Questions

When is INLEXZO (gemcitabine intravesical system)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for INLEXZO (gemcitabine intravesical system); 1 FDA decision is on record below.

What happened at INLEXZO (gemcitabine intravesical system)'s most recent FDA decision?

On Sep 9, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has INLEXZO (gemcitabine intravesical system) been approved by the FDA?

Yes. The FDA approved an application for INLEXZO (gemcitabine intravesical system) on Sep 9, 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.

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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