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* |
|---|---|---|---|---|
| 7. | Icotyde | icotrokinra | 3/17/2026 | To treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy |
| 6. | Lynavoy | linerixibat | 3/17/2026 | To treat cholestatic pruritus associated with primary biliary cholangitis |
| 5. | Yuviwel | navepegritide | 2/27/2026 | To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses |
| 4. | Loargys | pegzilarginase-nbln | 2/23/2026 | To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction |
| 3. | Bysanti | milsaperidone | 2/20/2026 | To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder |
| 2. | Adquey | difamilast | 2/12/2026 | To treat mild to moderate atopic dermatitis |
| 1. | Zycubo | copper histidinate | 1/12/2026 | To treat Menkes disease |
*The listed “FDA-approved use” on this page is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, please see the most recently approved Prescribing Information (or Label) available at Drugs@FDA. You can search by drug name, active ingredient, or application number.