SHANGHAI — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023. The two clinical updates include reporting the design of...
treatment News
SHANGHAI, China — Abbisko Therapeutics announced that its investigational innovative CSF-1R inhibitor pimicotinib（ABSK021) has been granted orphan drug designation by the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Following the successful ODD granted by the EMA, the product will benefit from incentives, including...
SHANGHAI, China — Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT). Pimicotinib is the first...
SHANGHAI, China — 13 January 2026 (Beijing Time), Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter, HKEX code: 02256.HK) announced today thatthe New Drug Application (NDA) for its novel, orally administered, highly selective, and potent small-molecule colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT),...
SHANGHAI, China — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter, HKEX code: 02256.HK) today announced that the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively...
NORTH CHICAGO, Ill. – AbbVie today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson’s medicinal products have not given satisfactory results. PRODUODOPA is...
NORTH CHICAGO, Ill. — AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these...
NORTH CHICAGO, Ill. — AbbVie (NYSE: ABBV) today announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The submission is based on data from the...
NORTH CHICAGO, Ill. — AbbVie (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering patients another VENCLEXTA combination regimen with the potential for time-limited...
NEWTON, Mass. — Abcuro, Inc., a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic, today presented interim data from the ongoing Phase 1/2 clinical trial evaluating ulviprubart...