FDAsafety guidance72% confidence
FDA AP — KEYTRUDA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck Sharp & Dohme LLC.
Regulatory Analysis
Application BLA125514. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: PEMBROLIZUMAB.
Supporting Context
- Therapeutic area
- Immunology · Lupus and Rheumatoid Arthritis
- Sub-indication
- General
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