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Keeping Track: Approvals For Xultophy, Soliqua And Darzalex; NDAs From Intarcia And GSK; Complete Response For Green Cross

 
• By Bridget Silverman

The latest drug development news and highlights from our FDA Performance Tracker

Type 2 diabetes took center stage in the days before the US Thanksgiving holiday as FDA approved two GLP-1 agonist/basal insulin combinations – Sanofi's Soliqua and Novo Nordisk AS's Xultophy – and received a submission from Intarcia Therapeutics Inc. for an implantable GLP-1 mini-pump. Here’s your news in brief:

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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New EU Approvals

 
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More from Product Reviews

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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