Bristol-Myers Squibb Co. said FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 CAR T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA has set a Prescription Drug User Fee Act goal date of Aug. 17.
For over a month since President Trump announced his intent to impose aggressive new tariffs on America’s friends and foes alike, lobbyists for hospitals, medical societies, and makers of branded and generic drugs have been trying to convince him to rethink.
