FDA approves Romvimza for tenosynovial giant cell tumor (TGCT)
The U.S. Food and Drug Administration (FDA) has approved vimseltinib (Romvimza) for adult patients with a rare condition ...
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Ono’s TGCT therapy wins FDA approval, challenging Daiichi Sankyo
TGCT is a rare, non-cancerous tumour affecting the joints, tendons, or joint tissue. It is linked to a CSF1 gene mutation ...
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FDA Approves Vimseltinib to Treat Tenosynovial Giant Cell Tumor
Discover Vimseltinib, the newly FDA-approved treatment for tenosynovial giant cell tumor (TGCT). Learn about its benefits, ...
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Ono poised to join Daiichi in TGCT market after FDA nod
Ono – which acquired rights to Romvimza when it bought Deciphera Pharma in a $2.4 billion deal that closed in 2023 – said ...
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Ono’s FDA Rare Cancer Approval Sets Up Face Off With Daiichi Sankyo
Ono picked up Romvimza—previously known by its active ingredient vimseltinib—from its $2.4 billion acquisition of Deciphera ...
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Ono Pharma Drug Acquired in $2.4B Deal Wins FDA Approval for Treating Rare Type of Tumor
The approval of the Ono drug, vimseltinib, covers the treatment of adults whose tenosynovial giant cell tumor (TGCT) cannot be surgically removed. The twice-weekly capsule will be marketed under ...
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Romvimza Approved for Symptomatic Tenosynovial Giant Cell Tumor
The Food and Drug Administration (FDA) has approved Romvimza ™ (vimseltinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will ...
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Second Drug for Benign Synovial Tumor Condition Wins FDA Approval
Opens in a new tab or window The FDA approved the small-molecule inhibitor vimseltinib (Romvimza) for adults with symptomatic tenosynovial giant cell tumor (TGCT), a rare, non-malignant ...
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U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
“The approval of ROMVIMZA provides a new, much-needed, well-tolerated, and effective treatment option for people suffering from TGCT,” said Hans Gelderblom, M.D., Ph.D., Chair of the ...
Medical Xpress4d
FDA approves Romvimza for tenosynovial giant cell tumor (TGCT)
Get Instant Summarized Text (Gist) The FDA has approved vimseltinib (Romvimza) for treating tenosynovial giant cell tumor (TGCT), a non-cancerous joint tissue tumor. In a Phase III trial, 67% of ...
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U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT) In the MOTION Phase 3 study, ROMVIMZA met primary ...