§1 Updates
Updates
Regulatory actions and trial results as they're reported, each one stating plainly what changed and what didn't — not what it might mean for you.
FDA advisory committee votes to recommend BPC-157 and TB-500 for pharmacy compounding, over agency staff's own objections
At its July 23-24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 to recommend adding both BPC-157 and TB-500 to the 503A Positive Bulk Drug Substances List, despite FDA staff's own briefing materials recommending against listing both substances, citing a lack of human injectable safety and efficacy data for either compound.
Retatrutide's TRIUMPH-2 and TRIUMPH-3 Phase 3 trials report positive topline weight-loss results
Eli Lilly announced topline results from two additional Phase 3 trials of retatrutide: TRIUMPH-2 (obesity with type 2 diabetes, n=1,152) reported weight loss of up to 20.8% and A1C reduction of up to 1.6 percentage points at the 12mg dose versus placebo; TRIUMPH-3 (obesity with established cardiovascular disease, n=1,949) reported weight loss of up to 22.6% at 80 weeks. These follow TRIUMPH-1's topline results reported earlier in 2026.
FDA advisory committee declines to recommend CJC-1295 for pharmacy compounding
At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee reviewed CJC-1295 — including its free-base, acetate, and DAC-linked forms — for potential addition to the 503A Positive Bulk Drug Substances List and voted against inclusion, citing nonclinical toxicity findings, immunogenicity risk, and an unresolved cardiac safety signal from a 2006 human trial that was terminated after a participant's death.