GAMMAGARD LIQUID
Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two y…
Category: US National Health Agency Sources
MNEXSPIKE
For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
MNEXSPI…
FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
TECARTUS
For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adul…
YESCARTA
For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months o…
ABECMA (idecabtagene vicleucel)
ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies includ…
FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because…
CARVYKTI
For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inh…
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends …
Never too late to sign up for VA benefits
For 45 years after they left military service, the Belangers relied on their private health insurance policies. Then they signed up for the VA benefit…