January 16, 2026
Clinical Updates
Cerezyme® (imiglucerase) – Expanded indication
January 12, 2026 - The FDA approved Sanofi’s Cerezyme (imiglucerase), for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients.
Drug Approvals
Zycubo® (copper histidinate) – New orphan drug approval
January 12, 2026 - The FDA approved Fortress Biotech’s Zycubo (copper histidinate), for the treatment of Menkes disease in pediatric patients.
Drug Safety
Glucagon-like peptide-1 receptor agonists – FDA requests removal of suicidal behavior and ideation warning
January 13, 2026 - The FDA requested that drug application holders remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language.