Iovance Biotherapeutics has carved out a piece of biotech history, becoming the first company to win FDA clearance for a cell therapy used to treat a solid tumour.
Iovance Biotherapeutics is facing a three-month delay in the review of its lifileucel cell therapy for melanoma in the US, held up by "insufficient resources" at the FDA.
Iovance Biotherapeutics could be a few months away from a first regulatory approval for lifileucel, which could be the first cell-based therapy for a solid tumour in the U
Investigator sites are essential for successful execution of clinical trials – ensuring studies are conducted ethically, safely, and in compliance with regulatory standards.