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FDA Approves Deciphera's ROMVIMZA™ (vimseltinib) for Adult Patients with Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

February 17, 2025 11:05 AM | Katy Monaco

FDA has approved ROMVIMZA™ (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. The FDA previously granted Fast Track designation and Priority Review for ROMVIMZA, which was developed by Deciphera Pharmaceuticals, Inc. (“Deciphera”), a wholly owned subsidiary of Ono.

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