Dated archive

Intelligence archive

Historical articles may no longer reflect current regulatory status. Check the cited primary source.

Historical regulatory articles

ARCHIVEApril 20, 2026

FDA schedules PCAC review for BPC-157, TB-500, MOTS-c, Semax, Epitalon (503A bulks pathway)

The FDA posted the July 23-24, 2026 PCAC agenda including multiple high-demand peptides used in practice, a regulatory access signal that moves these compounds into a formal 503A bulks list review process.

ARCHIVEApril 13, 2026

FDA Issues Import Alert 66-80: Foreign GLP-1 API Bulk Substances Subject to Detention

The FDA published Import Alert 66-80 enabling detention without physical examination of foreign-sourced GLP-1 API bulk substances including semaglutide and tirzepatide, citing cGMP and nonresponse concerns across evaluated manufacturing sites.

Intelligence archive — 6 articles

ResearchApril 13, 2026

Semaglutide Reduces Heart Failure Events in SOUL Trial Secondary Analysis

A secondary analysis of the SOUL randomized trial found that oral semaglutide was associated with fewer heart failure ev...

SemaglutideGLP-1Heart Failure

IndustryApril 13, 2026

Function Health Acquires Getlabs to Add At-Home Phlebotomy for Members

Function Health, the 160+ biomarker testing membership platform, acquired Getlabs to enable at-home blood draw for its m...

Function HealthGetlabsAcquisition

RegulatoryApril 6, 2026

FDA Reiterates GLP-1 Compounding Restrictions: Semaglutide and Tirzepatide Remain Off 503B Bulks List

The FDA issued an April 1, 2026 reminder clarifying compounding requirements for GLP-1 receptor agonists, reiterating th...

FDAGLP-1503A

ResearchApril 6, 2026

Semaglutide Reduces Cardiovascular Events in Liver Fibrosis Patients — Nature Medicine SELECT Analysis

A Nature Medicine analysis of SELECT trial data found that semaglutide reduced major adverse cardiovascular events (MACE...

SemaglutideGLP-1Liver Fibrosis