2025 Safety and Availability Communications
This webpage was developed to provide the public with important information about the safety and availability of biological products.
December 2025
- Update on the Safety of Andexxa
December 18, 2025
November 2025
- FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura
November 21, 2025 - FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients
November 14, 2025
October 2025
- Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions
October 24, 2025 - FDA approves labeling changes that include a Boxed Warning for Immune Effector Cell-associated Enterocolitis following treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
October 10, 2025
August 2025
- FDA Suspends the Biologics License for IXCHIQ Vaccine
August 22, 2025 - FDA Approves Required Labeling Changes for Increased Risk of Hematologic Malignancy Following Treatment with Skysona (elivaldogene autotemcel)
August 7, 2025 - FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)
August 6, 2025
July 2025
- FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies
July 18, 2025
June 2025
- FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
June 26, 2025 - FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
June 25, 2025 - FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS
June 24, 2025
May 2025
April 2025
- April 17, 2025 Safety Labeling Change Notification Letter - COVID-19 Vaccine, mRNA (COMIRNATY)
- April 17, 2025 Safety Labeling Change Notification Letter - COVID-19 Vaccine, mRNA (SPIKEVAX)