FDA Roundup: April 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the U.S. Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies. These completed changes follow a safety communication posted by the FDA in November 2023, and reflect requirements detailed in notification letters issued by the FDA in January 2024, to all manufacturers of the products in this class necessitating an update to the Boxed Warning ...