FDA Requests Removal of Suicidal Behavior/Ideation Warning from GLP‑1 RAs
On Jan. 13, 2026, the US Food and Drug Administration (FDA) asked manufacturers of several glucagon‑like peptide‑1 receptor agonists (GLP-1 RAs) to remove warnings about suicidal ideation and behavior from product labeling after a comprehensive review found no evidence linking the medications to such risks. The request applies to Saxenda® (liraglutide – Novo Nordisk), Wegovy® (semaglutide – Novo Nordisk), and Zepbound® (tirzepatide – Eli Lilly), all approved for weight management. The FDA said earlier warnings were based on reports associated with older weight‑loss drugs, but current data, including analyses of adverse event reports, clinical trials and observational studies, do not indicate an increased risk with GLP‑1 medications. Products used to treat type 2 diabetes do not carry suicidality warnings, and the agency said the update will ensure consistent labeling across the class. More information on the drug safety communication can be found here.
Cerezyme Gains Expanded FDA Indication for Broader Gaucher Disease Population
On Jan. 12, 2026, the FDA approved an indication expansion for Cerezyme® (imiglucerase – Genzyme Corporation), extending its use to treat non–central nervous system (CNS) manifestations of Type 1 and Type 3 Gaucher disease in adult and pediatric patients, including newly expanded eligibility for pediatric patients under two years of age. Initially approved in 1994 for the treatment of Type 1 Gaucher disease in adults and pediatric patients two years of age and older, specifically for non‑CNS manifestations, Cerezyme’s expanded approval broadens access to Type 3 and to earlier intervention in pediatric populations. Cerezyme replaces deficient β‑glucocerebrosidase activity, targeting the underlying glycolipid accumulation that drives Gaucher pathology. Cerezyme should be administered under the supervision of a healthcare provider experienced in managing hypersensitivity reactions, including anaphylaxis. The recommended intravenous (IV) dose ranges from 2.5units/kg three times a week to 60units/kilogram every two weeks, with adjustments based on disease severity and the patient’s treatment goals. Updated prescribing information can be found here.
Issues Document: Framework for Childhood Vaccination: 2026 CDC Immunization Schedule
On Jan. 5, 2026, the Centers for Disease Control and Prevention (CDC), under direction from the US Department of Health and Human Services (HHS), released a substantially revised US Childhood Immunization Schedule introducing a three-tiered framework emphasizing shared clinical decision-making and risk-based immunization. It is a significant shift from a long‑standing universal vaccination framework to a stratified approach. Driven by a December 2025 presidential memorandum, the revised schedule reduces the number of vaccines universally recommended for children while maintaining insurance coverage and access across federal and commercial programs. The attached document is intended to clarify what has changed, why the changes were implemented, and the potential implications of the revised framework.