January |
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| Drug | Description | FDA approved use | Company | FDA filing | Pathway | Date |
| Exa-cel (exagamglogene autotemcel) | An autologous, ex vivo CRISPR/Cas9 gene-edited therapy | Transfusion-dependent beta thalassemia (TDT) | Vertex Pharmaceuticals Inc., of Boston, and Crispr Therapeutics, of Zug, Switzerland | BLA | Standard | 1/16/2024 |
| Keytruda (pembrolizumab) | Anti-PD-1 therapy | High-risk locally advanced cervical cancer | Merck & Co. Inc., of Rahway, N.J. | sBLA | Priority | 1/12/2024 |
| Welireg (belzutifan) | Small-molecule inhibitor of hypoxia-inducible factor (HIF)-2a | Advanced renal cell carcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sNDA | Priority | 1/14/2024 |
| Zelsuvmi | Berdazimer topical gel, 10.3% | Molluscum contagiosum (molluscum) | Ligand Pharmaceuticals Inc., of San Diego | NDA | NME;Standard | 1/5/2024 |