The regulatory landscape saw several historic firsts in terms of in December. Among them are the approval of Bristol Myers Squibb's Breyanzi - the first CAR T-cell therapy for marginal zone lymphoma, and the introduction of TEMPO, a first-of-its-kind digital health pilot aimed at expanding access to chronic disease technologies, developed by the FDA's Center for Devices and Radiological Health. The FDA also cleared Gamida Cell Ltd.'s Omisirge, the first hematopoietic stem cell transplant therapy for patien ...