Industry/Regulatory Developments
The approved afamelanotide product is a 16 mg implant called Scenesse
FDA approved Scenesse in 2019 for adults with erythropoietic protoporphyria. The label describes an implant given…
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Industry/Regulatory Developments
Labels, compounding lists, and the gap between them.
Industry/Regulatory Developments
A cardiovascular trial result does not rewrite the label by itself
SELECT showed a cardiovascular difference with semaglutide 2.4 mg in a defined population. Whether a prescribing…
Industry/Regulatory Developments
Approved peptide medicines are defined by their labels
Tesamorelin, bremelanotide, semaglutide, and tirzepatide each became a specific product with an indication. A related research…
Industry/Regulatory Developments
Compounding rules and research-supply catalogs are different legal stories
FDA bulk-drug-substance lists govern compounding. A research-chemical storefront is not a pharmacy exception and not a…
Industry/Regulatory Developments
Tesamorelin reduced liver fat in a defined HIV trial. The indication did not widen by itself.
Stanley and colleagues reported less visceral fat and less liver fat in a randomized trial. The…