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August 18, 2025 12:30 ET | Source: ONWARD Medical NV

ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) The investigational device exemption (IDE) allows initiation of a...
January 22, 2024 07:59 ET | Source: Sixty Degrees Pharmaceuticals

60 Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine Following Jan 17 FDA Meeting

Post-FDA meeting, 60 Degrees Pharma plans pivotal study of tafenoquine in hospitalized babesiosis patients, aiming to start in summer 2024. #biotech #SXTP
February 15, 2023 16:01 ET | Source: SeaStar Medical Holding Corporation

SeaStar Medical Announces Details of the Selective Cytopheretic Device Pivotal Study in Critically ill Adults with Acute Kidney Injury

The NEUTRALIZE-AKI study will evaluate safety and efficacy of the SCD’s ability to target and neutralize the highly activated proinflammatory neutrophils and monocytes that drive hyperinflammation ...
June 28, 2018 07:00 ET | Source: uniQure Inc.

uniQure Enrolls First Patient in Phase III HOPE-B Pivotal Study of AMT-061 in Patients with Hemophilia B

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, June 28, 2018 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with...