Novel Drug Approvals for 2026
What are "Novel" Drugs?
"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
FDA Novel Drug Therapy Approvals for 2026
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 1. | Zycubo | copper histidinate | 1/12/2026 | To treat Menkes disease |