DATA GRAPHICS | Data Byte
At least 14 PDUFA dates on FDA’s August calendar
Most are subject to CDER review, but one CBER BLA remains after pair of early rejections
July 31, 2025 11:06 PM UTC
Following two early rejections by CBER for a cell and a gene therapy, FDA has at least 14 PDUFA dates remaining on its August docket.
Most of the applications fall under CDER’s jurisdiction, which covers small molecules, oligos and antibodies, but one is being reviewed by the beleaguered CBER, charged with gene and cell therapies. ...