FDAsafety guidance72% confidence
FDA AP — TRUTAKNA (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Eli Lilly.
Regulatory Analysis
Application BLA761486. Sponsor: VERA THERAPEUTICS INC.. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: ATACICEPT-VYMJ.
Supporting Context
- Therapeutic area
- Hematology · JAK2 Inhibition
- Sub-indication
- General
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