Review top news and interview highlights from the week ending January 13, 2023.
Welcome to CGTLive’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.
The FDA made the decision in response to manufacturing process information that it considered a major amendment.
The clinician scientist at St. Jude Children’s Research Hospital discussed the session on cell therapies in acute leukemias and Hodgkin lymphoma she moderated at ASH 2022.
The first patient dosed in the study experienced a case of prolonged pancytopenia that has required ongoing transfusion and growth factor support.
The assistant member of the bone marrow transplantation and cellular therapy department at St. Jude Children’s Hospital discussed preclinical research presented at ASH 2022.
The new analysis data was requested by the FDA ahead of the therapy’s March 31, 2023 PDUFA date.