FDA places partial clinical hold on BioNTech's experimental cancer drug BNT326/YL202 due to safety concerns and patient deaths.
The US FDA has placed a partial clinical hold on BioNTech SE's experimental cancer drug, BNT326/YL202, an antibody-drug conjugate, due to safety concerns and potential exposure of humans to unreasonable risks at higher doses. The FDA's decision follows three patient deaths in the trial, which has paused enrollment of new US patients, while BioNTech and MediLink must submit more pharmacological data and details on negative health outcomes.
June 17, 2024
6 Articles