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FDA

Regulatory intelligence
FDAsafety guidance72% confidence

Drug Trials Snapshots: PALSONIFY

Source: FDA

Why This Matters

Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Boehringer Ingelheim.

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
Pulmonology · Lung Fibrosis
Sub-indication
Immunology

Related signal: Boehringer Ingelheim's Nerandomilast Trial for Lung Fibrosis in Autoimmune Diseases

Source

View source document

Related Signal

Open signal — Boehringer Ingelheim's Nerandomilast Trial for Lung Fibrosis in Autoimmune Diseases
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