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Peptide news, regulatory, and FDA actions
The regulatory calendar that affects what your prescriber can prescribe, recent FDA actions on peptide and peptide-adjacent therapies, and our editorial reporting on news the briefs miss.
Regulatory calendar
View all events →- PCAC meetingJul 23, 2026 · in 2mo
PCAC “D-Day” for BPC-157 + TB-500 — Bulk Substances ruling
FDA Pharmacy Compounding Advisory Committee (PCAC) reviews BPC-157, TB-500, Thymosin α-1 and other peptides for inclusion on the 503A/503B compounding bulk substances list. The 'D-Day' for compounded recovery peptides.
Affects: BPC-157 · TB-500 · Thymosin α-1 · CJC-1295 · …
- FDA proposed ruleAug 3, 2026 · in 3mo
FDA 503B exclusion proposal for semaglutide + tirzepatide — public comment closes
Public comment period closes on the May 4, 2026 FDA proposed rule excluding semaglutide and tirzepatide from the 503B Outsourcing Facility bulks list. After this, the FDA reviews comments and may issue a final rule.
Affects: Semaglutide · Tirzepatide · Wegovy · Zepbound · …
- Policy / executive actionOct 15, 2026 · in 5mo
MAHA peptide-access framework — expected HHS rollout
The HHS / Make America Healthy Again administration is expected to publish a peptide-access framework in Q4 2026 — outlining 'Ethical Channel' compounding pathways and signaling potential FDA Category reclassification for non-injectable peptides.
Affects: BPC-157 · Sermorelin · Cerebrolysin · GHK-Cu · …
Recent FDA actions
View all alerts →No FDA actions in the last 30 days. The cron pipeline pulls from Drug Safety, MedWatch, PCAC, and Drug Shortages on the hour.
Editorial news
- marketMay 6, 2026
How the May 503B proposal affects HIMS, Mochi, and the DTC compounded GLP-1 market
The May 4 FDA 503B exclusion proposal directly affects the supply chain that DTC peptide telehealth (Hims & Hers, Mochi, Henry Meds) depends on. We map who is exposed, who has 503A fallbacks, and what patients on compounded GLP-1s should expect over the next 6-18 months.
- regulatoryMay 4, 2026
FDA opens public comment on excluding semaglutide and tirzepatide from 503B bulks list
The FDA proposed rule published May 4, 2026 would prohibit 503B outsourcing facilities from compounding semaglutide and tirzepatide as bulk substances. Public comment runs through August 3, 2026. Compounded GLP-1 supply is materially affected.
- regulatoryApr 15, 2026
PCAC July 23, 2026 meeting will review BPC-157 and TB-500 for the 503A bulks list
The Pharmacy Compounding Advisory Committee will vote on adding BPC-157 and TB-500 to the 503A bulks list at its July 23, 2026 meeting — the first formal regulatory review for both molecules. A favorable vote would clarify the legal-grey-area status these peptides have occupied since 2023.
- clinical-trialApr 8, 2025
SURMOUNT-5: tirzepatide outperforms semaglutide head-to-head (20.2% vs 13.7%) over 72 weeks
Lilly's SURMOUNT-5 (NEJM, April 2025) is the first head-to-head Phase 3 RCT of tirzepatide vs semaglutide for weight loss. Tirzepatide produced 20.2% mean weight loss vs semaglutide's 13.7% at week 72; 65% of tirzepatide patients achieved ≥15% loss vs 32% on semaglutide. Discontinuation rates were similar.
- regulatoryDec 20, 2024
FDA approves tirzepatide (Zepbound) for moderate-to-severe obstructive sleep apnea
Tirzepatide became the first GLP-1 class drug approved for obstructive sleep apnea on December 20, 2024. The SURMOUNT-OSA trials showed substantial AHI reduction in adults with obesity-associated moderate-to-severe OSA. The indication broadens beyond pure weight loss into a documented obesity comorbidity.
- clinical-trialJun 26, 2023
Retatrutide TRIUMPH-1 Phase 2: 24% mean weight loss at 48 weeks with triple-agonist mechanism
Retatrutide (Lilly) is a GLP-1 / GIP / glucagon triple agonist. TRIUMPH-1 Phase 2 (Jastreboff 2023, NEJM) reported 24.2% mean weight loss at 48 weeks in adults with obesity — substantially exceeding both tirzepatide and semaglutide trial benchmarks. Phase 3 TRIUMPH program is enrolling.