The agency cites safety concerns with customers of Genetech who reported getting E. coli infections and sends letters to other stem cell companies reminding them to follow the rules.
The biotech company Verve Therapeutics launched the study with the aim of using base editing to treat a genetic condition that causes high cholesterol and increases a person's risk of developing cardiovascular disease.
Studies show that a fourth mRNA vaccine dose offers the elderly and other high-risk groups strong protection against hospitalization and death from COVID-19, but experts say benefits for other populations may be more limited.
The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.
So-called laboratory-developed tests will eventually face regulations similar to those that currently govern diagnostic tests or kits that are sold to hospitals.