April 16, 2026
FDA Removes 12 Popular Peptides from Category 2: What This Means for Peptide Entrepreneurs
HHS Secretary Robert F. Kennedy Jr. announced a key regulatory change that could open doors for the peptide industry.
Read ArticleMay 27, 2026
CordenPharma Acquires AmbioPharm, Strengthening US and China Peptide API Supply
CordenPharma acquires AmbioPharm adding facilities in South Carolina and Shanghai, expanding peptide API manufacturing across three continents.
Read ArticleMay 29, 2026
FDA Issues Sweeping Import Alert on Foreign Peptide API Manufacturers
FDA expands Import Alert 66-40 to cover 38 foreign peptide API manufacturers across China, India, and South Korea, impacting ~30% of US injectable peptide supply.
Read ArticleJune 4, 2026
PharmaBlock Sciences Commissions First Peptide Pilot-Scale GMP Plant
PharmaBlock Sciences opens a 600L SPPS GMP pilot plant at its Zhejiang site, supporting scale-up from R&D to pilot-scale peptide API production.
Read ArticleJune 9, 2026
Peptide API Manufacturing Reshoring Accelerates as BIOSECURE Act Reshapes Supply Chains
An estimated $3.1B in reshoring-related peptide manufacturing investment has been announced since January 2025, driven by the BIOSECURE Act and supply chain risk.
Read ArticleJune 14, 2026
FDA Warning Letters to Peptide Suppliers: A Pattern Analysis (2024–2025)
Analysis of FDA warning letters issued to peptide suppliers from 2024 to 2025 reveals consistent patterns in unapproved drug marketing, GMP violations, and the limits of "research use only" disclaimers.
Read ArticleJune 14, 2026
EMA’s New Synthetic Peptide Guideline: What It Means for Quality Standards
The EMA’s first-ever dedicated Guideline on the Development and Manufacture of Synthetic Peptides took effect June 1, 2026. Here is what the document actually requires.
Read ArticleJune 14, 2026
Peptide CDMO Market Landscape: Bachem, PolyPeptide, Lonza, and the Capacity Race
Real financial data and capacity details for the three biggest peptide CDMOs, plus market sizing and what the capacity crunch means for buyers.
Read ArticleJune 11, 2026
cGMP Compliance Updates for Peptide Manufacturers: What Changed in 2026
FDA and EMA have issued updated GMP guidance for peptide drug manufacturers, with new requirements for process validation, impurity control, and quality systems.
Read Article