FDAsafety guidance66% confidence
FDA AP — REVLIMID (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Bristol Myers Squibb; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA021880. Sponsor: BRISTOL MYERS SQUIBB. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: LENALIDOMIDE.
Supporting Context
- Therapeutic area
- Oncology · Immune Checkpoint Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for YERVOY (ipilimumab) by Bristol Myers Squibb