FDAsafety guidance65% confidence
FDA AP — EBGLYSS (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Eli Lilly.
Regulatory Analysis
Application BLA761306. Sponsor: ELI LILLY AND CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LEBRIKIZUMAB-LBKZ.
Supporting Context
- Therapeutic area
- Obesity · GLP-1 Agonists
- Sub-indication
- General
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