Romvimza is a medicine called a kinase inhibitor that is used to treat tenosynovial giant cell tumor (TGCT) that may be made worse by surgery. TGCT is a condition where tumors form in joints of the ...

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 ...

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 ...

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 ...

The U.S. Food and Drug Administration (FDA) has approved vimseltinib (Romvimza TM) for adult patients with a rare condition called tenosynovial giant cell tumor (TGCT). TGCT is a tumor of the tissue ...

First regulatory approval in the world for pimicotinib based on positive data from global Phase 3 MANEUVER study In MANEUVER, pimicotinib significantly improved objective response rate at week 25 (54% ...

DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application ...

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug ...