The FDA announced several regulatory actions the past few weeks.
Regulatory
Iovance to Address FDA Requests for BLA of Lifileucel in Advanced Melanoma
After receiving recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel (LN-44) in the treatment of advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application (BLA) submission during the first quarter of 2023.
Bendigo Health unveils new machine with 3D imaging to help diagnose melanoma quicker
After receiving recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel (LN-44) in the treatment of advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application (BLA) submission during the first quarter of 2023.
FDA grants orphan drug designation to AVS100 for advanced melanoma
The FDA granted orphan drug designation to AVS100 for the treatment of stage IIB through stage IV melanoma, according to the agent’s manufacturer.