FDA pushes back decision on J&J, Legend's BCMA CAR-T

FDA pushes back decision on J&J, Legend's BCMA CAR-T

Source: 
Endpoints
snippet: 

Bristol Myers Squibb and bluebird can hold on to their status as the makers of the only approved BCMA CAR-T for a bit longer.

The FDA — which was scheduled to make a decision on Legend and J&J’s cilta-cel on Nov. 29 — has delayed that by three months and extended the PDUFA date to Feb. 28.