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SHANGHAI, China — Abbisko Therapeutics Co., Ltd. announced the completion of patient enrollment for its pivotal Phase III trial, MANEUVER (ABSK021-301) STUDY, for evaluating the efficacy and safety of pimicotinib in patients with tenosynovial giant cell tumor (TGCT). A total of 94 patients were enrolled and exceeded the original target...
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...
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...
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...
NEW YORK and CLEVELAND – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the activation of a second clinical trial site in its pivotal Phase 3 VIITAL™ study of its investigational EB-101 treatment for recessive dystrophic epidermolysis bullosa (RDEB) at UMass Memorial Medical Center...