Vascular Flow Articles & Analysis
5 news found
Gesynta Pharma AB today announces that all patients have been recruited for the company's clinical Phase II study with the drug candidate GS-248, which is being evaluated as a treatment for the rare disorder systemic sclerosis.The study is intended to demonstrate proof-of-concept and to evaluate the safety profile of GS-248. Top-line data is expected in the fall of 2022. Systemic ...
Gesynta Pharma AB today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud's phenomenon secondary to systemic sclerosis. Orphan Drug Designation is intended to encourage the ...
Gesynta Pharma AB today announced that an IND (Investigational New Drug Application) has been submitted to the U.S. Food & Drug Administration for its oral drug candidate GS-248 in patients with systemic sclerosis. Concurrently, more than half of the patients in the ongoing Phase II study in four countries across Europe have been recruited. The study investigates the safety of GS-248 and ...
Gesynta Pharma AB today announced that the first patients have been dosed in a Phase II study of its oral drug candidate GS-248 in patients with systemic sclerosis - a debilitating autoimmune disease that causes serious damage to the microvasculature. This proof-of-concept study will investigate the safety of GS-248 and its efficacy on Raynaud's phenomenon and peripheral blood flow in this ...
The Cellvizio®100 series system with all its different Confocal Miniprobes™ is now cleared for use with the fluorescein dye to image blood flow in the microvasculature and capillaries Mauna Kea Technologies today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Cellvizio® 100 series and all associated Confocal Miniprobes™ for ...