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May 28, 2021
U.S. FDA Accepts Biologics License Application for Ryzneuta™
May 28, 2021, Singapore – Evive Biotech, a global biologics company developing novel biological therapies, today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s submission of a Biologics License Application (BLA) for Ryzneuta™ (also known as F-627), a novel treatment for chemotherapy-induced neutropenia (CIN). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 30, 2022.
For more information on Evive’s BLA submission for Ryzneuta™, please click here.
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