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FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumor (TGCT)

Dr. William Tap led the development of vimseltinib for tenosynovial giant cell tumor. The U.S. Food and Drug Administration (FDA) has approved vimseltinib (Romvimza TM) for adult patients with a rare ...
Business Wire

U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell ...

OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Ono Pharmaceutical, Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) today announced that the U.S. Food and Drug Administration ...
Medscape

EMA Recommends Romvimza for Tenosynovial Giant Cell Tumor

At its July 2025 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization in the European Union for Romvimza ...
Cure Today

Emactuzumab Gets Fast Track Designation in Tenosynovial Giant Cell Tumors

Emactuzumab has received FDA fast track designation for TGCT treatment, aiding development for conditions lacking effective options. The phase 3 TANGENT trial evaluates emactuzumab, a CSF-1R ...
Medscape

FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumors

The US Food and Drug Administration has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult patients with symptomatic tenosynovial giant cell tumors (TGCT) who will not ...