28 stories
FDA approved oral Wegovy (semaglutide) based on OASIS 4 trial showing significant improvements in glycemic control and cardiovascular risk factors. Novo Nordisk plans full US launch from North Carolina manufacturing.
Analyzes the announcement that ~14 of 19 peptides on FDA's Category 2 list will move back to Category 1, restoring access through licensed compounding pharmacies with a prescription.
APC CEO Scott Brunner discusses the regulatory landscape for compounded GLP-1 receptor agonists amid increasing scrutiny and legal battles over compounded peptide drugs.
The FDA approved a new formulation of tesamorelin, the only approved treatment for HIV-associated excess abdominal fat, representing continued investment in peptide therapeutics for rare conditions.
Updated explainer clarifying BPC-157 is not outright banned but in Category 2 requiring further investigation. Discusses potential shifts after public statements about moving peptides back to Category 1.
The FDA held a public meeting to discuss broadening supplement ingredient criteria to include peptides, probiotics, and other substances. This is the first such meeting since RFK Jr. became HHS Secretary.
Health Secretary Kennedy announced on Joe Rogan's podcast that the FDA will soon reclassify about 14 peptides currently restricted from compounding pharmacies, aiming to curb gray-market sourcing.
The FDA granted breakthrough therapy designation to survodutide, a dual glucagon/GLP-1 receptor agonist by Boehringer Ingelheim, for treating adults with MASH.
FDA approved setmelanotide (IMCIVREE), an MC4R agonist peptide, for reducing body weight in adults and children aged 4+. Phase 3 TRANSCEND trial showed 18.4% placebo-adjusted BMI reduction at 52 weeks.
The FDA approved a new 2 mg dose of Ozempic (semaglutide) injection, providing an additional option for patients needing more intensive glycemic management.