InVia Fertility Specialists, PLLC – 710632 – 06/13/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Category: US National Health Agency Sources
Marine Veteran says, “Thank you” with Art
After VA discovered a tumor that others dismissed, Marine Veteran Chester Zaremba found a powerful way to say thank you—through diamond art.
GAMMAGARD LIQUID
Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two y…
Nirwana Foods Issues Allergy Alert on Undeclared Sulfites on Golden Raisin 28Oz Pouch Label
Nirwana Foods of NJ is recalling its 28-ounce pouches Golden Raisin with lot number (24/351-2410) because they may contain undeclared sulfites. People…
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…