Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved Pimjetmi (pimicotinib) on Nov 10, 2026. It is a Merck KGaA (EMD Serono) program in adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity. 1 FDA decision on record below. Every date links its source.
FDA approval tracked on pdufa.bio: adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity (approved Nov 10, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Merck KGaA (EMD Serono) (MKKGY). Market-cap tier at the time we tracked it: Large. 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.
When is Pimjetmi (pimicotinib)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for Pimjetmi (pimicotinib); 1 FDA decision is on record below.
What happened at Pimjetmi (pimicotinib)'s most recent FDA decision?
On Nov 10, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is Pimjetmi (pimicotinib) used for?
In our records Pimjetmi (pimicotinib) is FDA-approved for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity (approved Nov 10, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Who makes Pimjetmi (pimicotinib)?
Merck KGaA (EMD Serono) (MKKGY).
Has Pimjetmi (pimicotinib) been approved by the FDA?
Yes. The FDA approved an application for Pimjetmi (pimicotinib) on Nov 10, 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.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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