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pdufa.bio

MK-6240

Updated ยทnext FDA decision on the calendar

MK-6240 is a Lantheus Holdings Inc. program. The FDA approved it on Aug 13, 2026. 1 FDA decision on record below. Every date links its source.

LNTH catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Lantheus Holdings Inc. (LNTH). Market-cap tier at the time we tracked it: Mid. 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 · Aug 13, 2026 ✓ ApprovedLNTH

Questions

When is MK-6240's next FDA decision or readout?

No upcoming catalyst is on our calendar for MK-6240; 1 FDA decision is on record below.

What happened at MK-6240's most recent FDA decision?

On Aug 13, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes MK-6240?

Lantheus Holdings Inc. (LNTH).

Has MK-6240 been approved by the FDA?

Yes. The FDA approved an application for MK-6240 on Aug 13, 2026; 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.