For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
MNEXSPIKE is approved for use in individuals who have been…

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL).

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is…

ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and…

The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.

For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent parts, and outline requirements and…

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…