The FDA announced several regulatory actions the past few weeks.
Here is an overview of decisions that may be relevant to your practice.
1. The FDA issued a ”safe to proceed” for an investigational new drug application for NY-ESO-1 TCR/IL-15 NK (Syena) — an engineered cell therapy comprised of cord blood-derived natural killer cells — for treatment of advanced synovial sarcoma and myxoid/round cell liposarcoma.
2. The agency granted orphan drug designation to inobrodib (CellCentric) for treatment of multiple myeloma. Inobrodib binds to a specific part of proteins p300 and
