| Approved Name | Example Trade Names | Context | Status | Guidance | New Entry |
|---|---|---|---|---|---|
| Bulevirtide | Hepcludex | Red | NEW | ||
| Efgartigimod | Vyvgart | Red | NEW | ||
| Elranatamab | Elrexfio | Red | NEW | ||
| Epcoritamab | Tepkinly | Red | NEW | ||
| Evinacumab | Evkeeza | Red | NEW | ||
| Metyrapone | Amber | NEW | |||
| Mirikizumab | Omvoh | Red | NEW | ||
| Niraparib / Abiraterone | Akeega | Red | NEW | ||
| Nivolumab / Relatlimab | Opdualag | Red | NEW | ||
| Olipudase alfa | Xenpozyme | Red | NEW | ||
| Pegunigalsidase alfa | Elfabrio | Red | NEW | ||
| Vutrisiran | Amvuttra | Red | NEW |
