Peptide industry news.
FDA regulatory action, clinical trial readouts, and peptide pipeline developments — paraphrased from primary sources by the Grey Peptides News Desk. Every post links to its original source.
REDEFINE-1 Body Composition Data: How CagriSema Affects Muscle Mass
New post-hoc DXA findings from Novo Nordisk's pivotal CagriSema trial, presented at the European Congress on Obesity 2026, examine the muscle-mass and lean-tissue picture behind 20%+ weight loss.
The FDA Just Proposed Ending Mass GLP-1 Compounding — Here's What It Actually Means
On April 30, the FDA published a proposed rule that would permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The compounding workaround is closing — but slower than the headlines suggest.
PIONEER TEENS: Oral Semaglutide Posts Positive Phase 3 Results in Pediatric Type 2 Diabetes
Novo Nordisk reported topline results from a phase 3a trial of oral semaglutide in patients aged 10 to 17 with type 2 diabetes — the first oral GLP-1 RA to clear a pivotal study in this group.
FDA Pulls 12 Peptides Off Its "Do Not Compound" List — What Changes, and What Doesn't
On April 15, the FDA quietly removed twelve peptide bulk substances from Category 2 of the 503A interim policy. A July advisory-committee vote will decide whether they actually become compoundable.
Wegovy HD Cleared in 54 Days: What the FDA's New Voucher Pathway Means for Peptide Drugs
The FDA approved semaglutide 7.2 mg on March 19 — fifty-four days after filing — using the Commissioner's National Priority Voucher pathway. Faster reviews are great. The precedent is more complicated.
Foundayo (Orforglipron) Approved: The First Oral Small-Molecule GLP-1 for Weight Loss
On April 1, the FDA approved Eli Lilly's orforglipron under the brand Foundayo. Unlike oral Wegovy, it's a small-molecule pill that doesn't require an empty stomach — and pricing is undercutting injectables.
All news posts are paraphrased from primary sources. Each post links to its original publication. Read more about how the News Desk operates or subscribe via RSS.