On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
9/5/2025
/ Administrative Procedure Act ,
Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
PHSA ,
Product Labels ,
Public Health ,
Regulatory Authority ,
Regulatory Oversight ,
Statutory Interpretation ,
Vaccinations
FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant...more