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MediLink and BioNTech implement risk mitigation measures.
August 19, 2024
By: Charlie Sternberg
Associate Editor
The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on MediLink Therapeutics (Suzhou) Co., Ltd.’s Phase I trial evaluating BNT326/YL202 (NCT05653752). The decision follows the submission of a comprehensive response by MediLink, addressing the FDA’s concerns regarding safety data and incorporating additional risk mitigation measures. BNT326/YL202 is a HER3-targeting antibody-drug conjugate (ADC) being developed in collaboration with BioNTech SE. T...
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