News and updates.

EMA Guideline on Development and Manufacture of Synthetic Peptides

FDA 503A Category System

Peptide Regulatory Timeline 2024-2026

FDA Warning Letters to 7 Peptide Companies (April 2026)

FDA Approves Higher-Dose (7.2 mg) Wegovy Under National Priority Voucher Program

FDA approved a new higher 7.2 mg dose of Wegovy (semaglutide) for weight loss and long-term maintenance. Fourth product approved under the National Priority Voucher Program, signaling continued institutional support for GLP-1 obesity treatments.

Peptide Sciences Voluntary Shutdown

FDA Issues 30 Warning Letters to Telehealth Companies for Illegal Marketing of Compounded GLP-1s

FDA announced 30 warning letters to telehealth companies for false or misleading claims regarding compounded GLP-1 products offered on their websites.

HHS Secretary Kennedy Announces Potential Peptide Reclassification

TGA Australia Tightens Peptide Import Restrictions

Science.bio Voluntary Shutdown

FDA Issues 55+ Warning Letters to GLP-1 Compounders

Eli Lilly and Novo Nordisk Lawsuits Against GLP-1 Compounders

Amino Asylum FDA Raid — First Physical Enforcement Action Against Peptide Vendor

DOJ Criminal Prosecutions of Peptide Distributors (2024-2025)

FDA Revised Interim Policy on Compounding — End of Category System for New Nominations

State-Level Peptide Enforcement Actions (2025-2026)

Semaglutide and Tirzepatide Compounding Shortage Resolution

FDA Category 2 Designations for Peptides (2023-2024)