GLP-1 compounding is moving from shortage-era access to enforcement-era scrutiny.
The tracker prioritizes FDA shortage notices, 503A and 503B policy, warning letters, and OIG oversight signals.
A source-first queue for FDA actions, GLP-1 compounding policy, warning letters, anti-doping rules, pharmacy oversight, and trade-body responses. These are not rewritten press releases; every item starts with the source that should anchor the article.
The tracker prioritizes FDA shortage notices, 503A and 503B policy, warning letters, and OIG oversight signals.
When FDA flags dosing errors, sterility, or CGMP concerns, the relevant profile and access pages should get revised.
WADA is treated as the source of record for anti-doping status, with clinical evidence handled separately.
Samsung Biologics Acquires Swiss CDMO, Enters Obesity Drug Market 2.7 trillion won deal boosts peptide-based treatments for obesity and diabetes Samsu
Medriva tracks current peptide, GLP-1, regulatory, clinical, and industry coverage, then keeps the most relevant developments here for brief selection and editorial follow-up.
Samsung Biologics Co. will acquire Switzerland’s PolyPeptide Group AG in an all-cash tender offer valued at about CHF1.46 billion ($1.86 billion), markin
SEOUL, July 20 (Yonhap) -- Samsung Biologics Co. said Monday it will acquire a Swiss-based...
Samsung Biologics Acquires Swiss CDMO, Enters Obesity Drug Market 2.7 trillion won deal boosts peptide-based treatments for obesity and diabetes Samsu
Medriva is tracking this as a current peptide-news lead for review against the original publisher page.
Samsung Biologics announced it will acquire PolyPeptide Group, a Swiss-based peptide contract development and manufacturing organization (CDMO), for…
Medriva is tracking this as a current peptide-news lead for review against the original publisher page.
Medriva is tracking this as a current peptide-news lead for review against the original publisher page.
Samsung Biologics is acquiring Swiss peptide CDMO PolyPeptide Group for about 2.7 trillion won via a tender offer, expanding beyond antibody drugs into the peptide field.
Samsung Biologics buys PolyPeptide to enter peptide CDMO, expand global footprint Deal marks Koreas largest bio M&A as Samsung Biologics secures six s
Medriva is tracking this as a current peptide-news lead for review against the original publisher page.
The booming industry selling Australians on treatments to live longer is exploiting significant gaps in health regulation, exposing consumers to risk.
Medriva is tracking this as a current peptide-news lead for review against the original publisher page.
Merck’s Lipfendra is the first FDA-approved pill in the class of cholesterol-lowering drugs called PCSK9 inhibitors. While peptides are typically injected, Lipfendra is a macrocyclic peptide designed for formulation as an oral drug.
Medriva is tracking this as a current peptide-news lead for review against the original publisher page.
Source-led briefs and editorial dispatches are collected here after publication. Search by month, date, drug, regulator, or source theme, then open the archived item directly.
Each card links to the originating source and labels the regulatory, safety, clinical, or industry context that may need a future Medriva update.
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
Main FDA Warning Letter Page
Inspections, recalls and other actions of compounders under section 503A and outsourcing facilities under section 503B
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Peptide hormones, growth factors, mimetics, and athlete-facing restrictions.
News and more from the Alliance for Pharmacy Compounding
Information relating to FDA recognized Drug Shortages and the Outsourcing Facility Association or OFA
Get caught up with the latest in NABP pharmacy news. Access official news releases, program updates, reports, as well as blog posts from industry experts.
Press Announcements
FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information.
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ClinicalTrials.gov Show glossary Search for terms Hide glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
The proposal would keep 503B outsourcing facilities from compounding these GLP-1 active ingredients from bulk drug substances unless another legal pathway applies.
OIG flagged a review of FDA oversight for compounded GLP-1 drugs, with a final report expected later in the decade.
FDA identified CGMP and sterility-related concerns at a 503B outsourcing facility and tied the review to compounded drug products including GLP-1 preparations.
FDA said companies were making illegal marketing claims around compounded GLP-1 products and failing to communicate required risk context.
FDA outlined enforcement-discretion end dates after resolving tirzepatide and semaglutide shortage status, with different windows for 503A and 503B compounders.
FDA highlights dosing errors, adverse-event reports, and risks from unapproved GLP-1 products, including non-commercial active ingredients promoted online.
The prohibited list is the athlete-facing source for peptide hormones, growth factors, related substances, and mimetics.
The trade-body response is useful context for industry arguments, but it should be treated separately from FDA policy.