FDAsafety guidance83% confidence
Drug Trials Snapshots: PALSONIFY
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Bayer.
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
- Gynecology · Endometrial Hyperplasia
- Sub-indication
- General
Related signal: Bayer's Mirena Investigated for Nonatypical Endometrial Hyperplasia Treatment