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Nov 10, 2026Regulatory decision

FDA approves pimicotinib for symptomatic tenosynovial giant cell tumor

The agency cleared the kinase inhibitor, sold as Pimjetmi, for adults whose TGCT surgery could cause worse function or severe morbidity.

The FDA approved pimicotinib on November 10, 2026, under the brand name Pimjetmi from EMD Serono, Inc. The drug is a kinase inhibitor approved for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity.1

The approval record does not include additional details on trial data, dosing, or label specifics. The source material available does not describe what TGCT is or how common it is, nor does it specify the anatomical structures involved in the condition.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.