BLA 761391, held by Galderma Labs LP. Nemolizumab-Ilto.
As of Nov 14, 2026, BLA 761391 (Nemluvio), held by Galderma Labs LP, was first approved by FDA on Dec 13, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nemluvio30mg · injectable;injection | Nemolizumab-Ilto | Rx |
| Jun 26, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Dec 13, 2024 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
