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Second Drug for Benign Synovial Tumor Condition Wins FDA Approval

Summary by MedPage Today

(MedPage Today) -- The FDA approved the small-molecule inhibitor vimseltinib (Romvimza) for adults with symptomatic tenosynovial giant cell tumor (TGCT),

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MedPage Today

Second Drug for Benign Synovial Tumor Condition Wins FDA Approval

(MedPage Today) -- The FDA approved the small-molecule inhibitor vimseltinib (Romvimza) for adults with symptomatic tenosynovial giant cell tumor (TGCT),

9 days ago·New York, United States

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pipelinereview

U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT) - Pipelinereview

In the MOTION Phase 3 study, ROMVIMZA met primary endpoint of improved objective response rate (ORR) compared to placebo and all key secondary endpoints with statistically significant and clinically meaningful improvements in quality-of-life measures, and demonstrated well-tolerated safety profile OSAKA, Japan & WALTHAM, MA, USA I February 14, 2025 I Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) annou…

8 days ago

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Pharmacy Times

FDA Approves Vimseltinib for the Treatment of Adults With Symptomatic TGCT

The indication is for symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

9 days ago

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