Home » FDA Pushes Back Review of BMS Lymphoma Treatment
FDA Pushes Back Review of BMS Lymphoma Treatment
The FDA pushed back its decision date by three months for Bristol Myers Squibb’s lisocabtagene maraleucel (liso-cell) for relapsed or refractory large B-cell lymphoma.
The FDA accepted the Biologics License Application (BLA) for the drug in February for priority review, and the agency was originally expected to make a decision on the drug by Aug. 17.
But BMS submitted additional information and the agency deemed that a major amendment requiring more review time. The company now expects a decision on the drug by Nov. 16.
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May