Bristol Myers Squibb said the U.S. health regulator deferred a decision on an experimental blood cancer therapy that the company acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
Bristol-Myers Squibb Company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for lisocabtagene maraleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies.