Peptide News
Automatically updated feed covering FDA updates, research findings, industry developments, and safety alerts related to peptides. Updated daily via AI web search. For research use only.
45 Articles
Pharmacy Compounding Advisory Committee Reviews Peptide Compounding Frameworks
The Alliance for Pharmacy Compounding (APC) recently engaged in a listening session with FDA staff to discuss proposed safety guardrails for peptide compounding.
Read sourceFDA Engages in Listening Session on Peptide Compounding Guardrails
The Pharmacy Compounding Advisory Committee and FDA staff held a session to discuss proposed technical frameworks for the utilization of specific peptides.
Read sourceFDA Advisory Committee Reviews Peptide Compounding Regulations
A July 2026 meeting of the Pharmacy Compounding Advisory Committee (PCAC) addressed the ongoing debate regarding the classification of restricted peptides.
Read sourceUpdated Regulatory Interpretations of ICH Q11 for Peptide API Manufacturing
New regional guidance has expanded the application of the ICH Q11 framework to provide more specific oversight for synthetic peptide manufacturing.
Read sourceP21 Cognitive Peptide Shows Hippocampal Activation in Recent Study
A study published in September 2026 reports that the P21 peptide demonstrated measurable improvements in hippocampal activation and memory consolidation.
Read sourcePhase 3 Research Findings on Survodutide Metabolic Impact
New research published in September 2026 indicates that the dual GLP-1/glucagon agonist Survodutide significantly reduced visceral adipose tissue and liver fat in preclinical and clinical models.
Read sourceViking Therapeutics Reports Positive Maintenance Data for VK2735 Peptide
A maintenance study of the GLP-1/GIP dual agonist peptide VK2735 demonstrated significant weight management outcomes in a preclinical and clinical research setting.
Read sourceViking Therapeutics Reports Positive Maintenance Data for VK2735 Peptide
Viking Therapeutics announced topline results from a maintenance study of its GLP-1/GIP dual agonist peptide, VK2735, demonstrating sustained weight loss outcomes.
Read sourceFDA Issues Warning Letters to Multiple Peptide Vendors Regarding Unapproved Claims
The FDA recently issued warning letters to several online peptide vendors for marketing research-grade substances as unapproved new drugs.
Read sourceFDA Updates Import Alert 66-80 Regarding GLP-1 Receptor Agonist Bulk Substances
The FDA has revised Import Alert 66-80 to implement detention without physical examination for certain foreign-sourced GLP-1 API shipments.
Read sourceFDA Expands Import Alert 66-80 to Address GLP-1 API Adulteration
The FDA has revised Import Alert 66-80 to implement detention without physical examination for various GLP-1 receptor agonist bulk drug substances due to significant compliance concerns.
Read sourceFDA Releases Updated Draft Guidance on Analytical Procedures for Peptide Drug Substances
New draft guidance from the FDA consolidates expectations for the characterization, impurity testing, and method validation of synthetic peptide drug substances.
Read sourceFDA Issues Five Warning Letters to Peptide Vendors Regarding Research-Use Claims
The FDA issued five coordinated warning letters on September 1, 2026, to online peptide vendors for marketing unapproved substances as research-use-only products while implying human drug intent.
Read sourceFDA Issues Warning Letters to Peptide Vendors Regarding Unapproved New Drug Claims
Recent FDA enforcement actions highlight the regulatory distinction between research-use chemicals and unapproved new drugs.
Read sourceFDA Issues Warning Letter to NuScience Peptides LLC Regarding Unapproved Peptide Distribution
The FDA issued a warning letter to NuScience Peptides LLC on August 24, 2026, citing the distribution of unapproved new drugs, including various GLP-1 and GLP-2 receptor agonists.
Read sourceRegulatory Status of Restricted Peptide Compounds Under Review
Recent administrative discussions have focused on the potential reclassification of several research peptides currently listed under the FDA's Category 2 restricted compounding list.
Read sourceFDA Updates Import Alert 66-80 Regarding GLP-1 Receptor Agonist Bulk Substances
The FDA has revised Import Alert 66-80 to update guidance for the detention of GLP-1 receptor agonist bulk drug substances.
Read sourceFDA Advisory Committee Evaluates Bulk Drug Substances for 503A Compounding
In July 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) reviewed seven peptide substances to determine their eligibility for the 503A bulk drug substances list.
Read sourceNew Analytical Method Enhances De Novo Sequencing of Short Peptides
Researchers at Kyushu University have developed a novel coumarin-tagging method to improve the accuracy of de novo sequencing for short peptides.
Read sourceFDA Grants Fast Track Designation to PVX108 Peptide Immunotherapy
The FDA has granted Fast Track designation to Aravax's investigational peptide immunotherapy, PVX108, for the study of peanut allergy.
Read sourceKylo Peptides Launches Multi-Component Peptide Stack for Laboratory Research
Kylo Peptides has introduced a new four-component research stack consisting of GHK-Cu, BPC-157, TB-500, and KPV for laboratory applications.
Read sourceFDA Publishes Revised Draft Product-Specific Guidances for Generic Peptide Development
The FDA released 17 revised draft product-specific guidances (PSGs) on July 28, 2026, to standardize the regulatory assessment of generic peptide products.
Read sourceFDA Publishes Revised Draft Product-Specific Guidances for Generic Peptide Development
The FDA has released 17 revised draft product-specific guidances (PSGs) to standardize the assessment of generic peptide drug substances.
Read sourceFDA Pharmacy Compounding Advisory Committee Reviews Status of Six Peptide Substances
An FDA advisory committee recently evaluated the inclusion of six specific peptides on the 503A Bulks List, marking a key step in the regulatory review process.
Read sourceFDA Releases Revised Draft Product-Specific Guidances for Generic Peptide Development
The FDA has published 17 revised draft product-specific guidances (PSGs) to standardize the assessment of generic peptide drug products.
Read sourceFDA Pharmacy Compounding Advisory Committee Recommends Inclusion of Six Peptides on 503A Bulks List
The FDA Pharmacy Compounding Advisory Committee has recommended adding six specific peptide substances to the 503A Bulks List following a July 2026 review.
Read sourceFDA Releases Revised Draft Product-Specific Guidances for Generic Peptide Development
The FDA has issued 17 revised draft product-specific guidances (PSGs) to standardize the regulatory assessment of generic peptide drug products.
Read sourcePharmacy Compounding Advisory Committee Reviews Bulk Drug Substances
The FDA's Pharmacy Compounding Advisory Committee (PCAC) recently evaluated several peptide substances for potential inclusion on the 503A bulk drug substances list.
Read sourceRegulatory Overview of Tesamorelin in Laboratory Research
Tesamorelin remains the only FDA-approved growth-hormone-releasing hormone (GHRH) peptide, with its regulatory history providing insights for the research community.
Read sourceFDA Advisory Committee Recommends Six Peptides for 503A Bulks List
In a July 2026 meeting, the FDA Pharmacy Compounding Advisory Committee recommended the inclusion of six specific peptides on the Section 503A Bulks List.
Read sourceFDA Updates Draft Guidance on Semaglutide Impurity Controls
The FDA has released revised draft guidance for semaglutide, establishing specific thresholds for active ingredient-related impurities in synthetic and recombinant peptide production.
Read sourcePharmacy Compounding Advisory Committee Evaluates Bulk Drug Substances
The FDA's Pharmacy Compounding Advisory Committee (PCAC) held meetings in July 2026 to evaluate the status of several peptides, including BPC-157 and TB-500.
Read sourceAdvancements in Computational Antimicrobial Peptide Discovery
Recent research published in Frontiers in Bioinformatics explores the integration of AI and big data to accelerate the discovery of novel antimicrobial peptides.
Read sourceAnalysis of Regulatory Standards for Peptide Impurity Thresholds
A June 2026 analysis by Oath Research highlights the stringent FDA requirements for identifying impurities in synthetic peptide applications.
Read sourceAnalysis of Regulatory Standards for Peptide Purity Verification
A recent industry analysis highlights that FDA guidance for synthetic peptides requires the identification of all impurities exceeding 0.10% of the active pharmaceutical ingredient.
Read sourceFDA Proposes Exclusion of Specific GLP-1 Agonists from 503B Bulks List
The FDA has proposed that semaglutide, tirzepatide, and liraglutide should not be included on the 503B bulk substances list.
Read sourceFDA Issues Warning Letter to Wholesale Peptide Regarding Regulatory Compliance
The FDA issued a warning letter to Wholesale Peptide on June 17, 2026, citing significant violations identified during a review of the company's website.
Read sourceFDA Issues Warning Letter to Wholesale Peptide Regarding Compliance
The FDA issued a warning letter to Wholesale Peptide in June 2026 following a review of website content and product offerings.
Read source2026 Peptide Industry Report Highlights Market Growth and Quality Disparities
A recent industry report indicates the global peptide market has reached $140 billion, while noting a widening quality gap in research-grade supply chains.
Read sourceRegulatory Status of Emideltide (DSIP) Scheduled for PCAC Review
The FDA has removed Emideltide (DSIP) from its Category 2 list and scheduled the compound for a Pharmacy Compounding Advisory Committee (PCAC) review.
Read sourceFDA Updates Guidance on Type II Drug Master Files for Peptide Substances
The FDA has released updated guidance for Type II Drug Master Files (DMFs) regarding peptide drug substances, emphasizing rigorous analytical characterization and process control.
Read sourceCordenPharma Announces Major Expansion of Peptide Manufacturing Capacity
CordenPharma is investing $500 million to expand its Boulder, Colorado facility, significantly increasing its solid-phase peptide synthesis (SPPS) capacity.
Read sourceEmerging Trends in Multi-Receptor Peptide Research
The landscape of metabolic research is shifting toward the development of combination formulations and four-receptor peptide compounds.
Read sourceFDA Issues Warning Letter Regarding Unapproved Peptide Distribution
The FDA issued a warning letter to Gram Peptides in March 2026 regarding the distribution of unapproved new drug products.
Read sourceFDA Issues Warning Letter Regarding Unapproved Peptide Distribution
A recent FDA warning letter highlights the regulatory risks associated with the distribution of unapproved peptide substances marketed for research use.
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