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Novo Nordisk files for FDA approval of a higher dose of Wegovy injection 7.2 mg
Novo Nordisk announced the submission of a sNDA to the FDA for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity. Under the CNPV expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing. The sNDA includes results from STEP UP, a 72-week phase 3, randomised, double-blind, placebo-controlled and active-control
US obesity organisations call for better testing and labelling of drugs for people with obesity
The Obesity Action Coalition (OAC) announces the publication of a ‘Joint statement in support of closing gaps in the drug approval...
FDA warns against using compounded semaglutide
The FDA has received adverse event reports after patients used compounded semaglutide for type 2 diabetes and weight loss. Drug...
nanoMesh files second PMA (510(k)) with FDA for Exogenesis Hernia Mesh
nanoMesh, a subsidiary of Exogenesis, has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with...
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