LBS-007, a novel targeted therapy, has received FDA fast track designation for the treatment of acute myeloid leukemia.
Regulatory
FDA Approves Nivolumab for Completely Resected Stage IIB/C Melanoma
Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.
FDA Approves Adjuvant Nivolumab for Stage IIB/IIC Melanoma
Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.
FDA Extends Priority Review of BLA for Lifileucel in Advanced Melanoma
The FDA has extended the priority review period for the biologics license application (BLA) seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.