Dankook University

FDA Grants Second Fast Track Designation to Alginomics' RZ-001 for Hepatocellular Carcinoma Treatment

3 months ago

• Alginomics' anticancer drug RZ-001 receives FDA Fast Track designation for hepatocellular carcinoma treatment, marking its second such designation following glioblastoma in November 2023. • The Fast Track status enables expedited review processes, enhanced FDA communication, and rolling reviews of data submissions, potentially accelerating the drug's development timeline. • This regulatory milestone reinforces RZ-001's potential as an innovative treatment option for patients with life-threatening cancers, according to Alginomics CEO Lee Seong-wook.