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 Tumor (TGCT) [Yaho...
ONO PHARM CO UNSP/ADR (OPHLY)
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Source: Yahoo! Finance
The U.S. FDA has assigned a target action date of February 17, 2025 EMA has accepted Deciphera's a Marketing Authorization Application for vimseltinib OSAKA, Japan & WALTHAM, Mass., August 15, 2024 BUSINESS WIRE )--Ono Pharmaceutical, Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; "Ono") today announced that the U.S. Food and Drug Administration (FDA) accepted a priority review for the New Drug Application (NDA) on August 14 US time for vimseltinib, a colony stimulating factor 1 receptor (CSF1R), for the treatment of patients with tenosynovial giant cell tumor (TGCT), which is under development by Deciphera Pharmaceuticals, Inc. ("Deciphera"), a wholly-owned subsidiary of Ono. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 17, 2025. In mid-July, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) of vimseltinib and has begun the start of the EMA's centralized review process. "Building upon p
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