New FDA Guidance Impacts the CAR-T Industry

In January, the FDA published, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products: Guidance for Industry.” To find out how this guidance impacts the CAR-T industry, GEN talked with Klara Sochorová, PhD, senior quality compliance...

BMS’s Breyanzi Becomes First CAR-T Therapy for Two Types of Leukemia

It isn’t often that a single company has an advisory committee meeting for one product and an FDA decision for another in the same week. Even more unusual is when the two drugs are of the same therapeutic class. That’s what’s happening this week for Bristol Myers...