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INLEXZO (gemcitabine intravesical system)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET

INLEXZO (gemcitabine intravesical system) The FDA approved it on Sep 9, 2025. 1 FDA decision on record below. Every date links its source.

JNJ catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

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

FDA decision · 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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