The US FDA’s approval of Ferring Pharmaceuticals’ bladder cancer gene therapy Adstiladrin just two weeks after the company took home an approval for the pioneering microbiome therapeutic Rebyota reshaped the Center for Biologics Evaluation and Research’s list of 2022 novel approvals by putting Switzerland-based Ferring on par with bluebird bio. The companies each received two novel approvals apiece.
Gene therapies stand as the dominant theme among CBER’s eight novel approvals in 2022 to date: Ferring’s Adstiladrin brings the...




