FDAsafety guidance72% confidence
Drug Trials Snapshots: PALSONIFY
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Biogen.
Regulatory Analysis
PALSONIFY is a somatostatin receptor analog for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Supporting Context
- Therapeutic area
- Immunology · Lupus
- Sub-indication
- General
Related signal: Biogen's Litifilimab (BIIB059) Study Targets Active Cutaneous Lupus Erythematosus