Tag: Mezzion

Mezzion Pharma Submits Protocol for Confirmatory Pivotal Phase 3 Trial (“FUEL-2”) in Fontan Subjects

SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA). In the Type B meeting between the FDA and Mezzion, the FDA provided Mezzion with a clear path forward […]

Mezzion Appoints William Breitenbach as Chief Commercial Officer for Mezzion’s Global Commercial Operations

SEOUL, Republic of Korea, June 15, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ), and Mezzion Pharmaceuticals, Inc. (individually or collectively, “Mezzion”), a leader in the field of rare single ventricle congenital heart disease (“SVHD”) and SVHD patients with Fontan circulation, is pleased to announce that Bill Breitenbach has joined Mezzion as the Chief Commercial […]

Mezzion’s New Drug Application (“NDA”) for its Orphan Drug Udenafil for the Treatment of Single Ventricle Heart Disease (“SVHD”) has been Accepted for Filing by the FDA

SEOUL, South Korea, May 25, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review […]

Mezzion Pharma’s new orphan drug udenafil improved ventricular function measured by myocardial performance index (MPI) in adolescents with congenital single ventricle heart disease (SVHD) – Further results from the pivotal 400-subject Phase 3 FUEL Trial

Mezzion Pharma files new patent applications to cover globally this important MPI advancement, a unique new finding as a result of treatment of SVHD patients with udenafil SEOUL, South Korea, May 18, 2020 /PRNewswire/ — Mezzion Pharma Co. Ltd. today announced that analysis of data from its Phase 3 FUEL trial showed statistically significant positive […]