| Approved Name | Example Trade Names | Context | Status | Guidance | New Entry |
|---|---|---|---|---|---|
| Belumosudil mesilate | Rezurock | Red | NEW | ||
| Capivasertib | Truqap | Red | NEW | ||
| Etranacogene dezaparvovec | Hemgenix | Red | NEW | ||
| Etrasimod | Velsipity | Red | NEW | ||
| Glofitamab | Columvi | Red | NEW | ||
| Nitisinone | Orfadin | Red | NEW | ||
| Pegzilarginase | Loargys | Red | NEW | ||
| Quizartinib | Vanflyta | Red | NEW | ||
| Ritlecitinib | Litfulo | Red | NEW | ||
| Sugemalimab | Eqjubi | Red | NEW | ||
| Voclosporin | Lupkynis | Red | NEW | ||
| Voxelotor | Oxbryta | Red | NEW | ||
| Zolbetuximab | Vyloy | Red | NEW |
