SEOUL, South Korea, April 25, 2023 /PRNewswire/ — Mezzion Pharma (“Mezzion”), a rare disease focused pharmaceutical company, announced that it has secured nearly $40M USD to fund FUEL-2, their confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries […]
Tag: Mezzion Pharma
Mezzion Pharma Receives Clear FDA Path Forward for the Approval of Udenafil for Single Ventricle Heart Disease
SEOUL, South Korea and BETHESDA, Md. , May 31, 2022 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil […]
Mezzion Pharma Announces Positive Data Presented to FDA in Type C Meeting
SEOUL, South Korea and BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of […]
Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
Submitted for FDA Priority Review as a Rare Pediatric Disease Product Application SEOUL, South Korea, March 28, 2021 /PRNewswire/ — Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for […]
Mezzion Announces Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
Submitted for FDA Priority Review as a Rare Pediatric Disease Product Application SEOUL, South Korea, June 30, 2020 /PRNewswire/ — Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for […]