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The FDA designated class II special controls classifications for two diagnostics and force separation catheters. 

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ProGen’s Dual Agonist Obesity Contender Gains Momentum With Rani Partnership

The CEO of South Korean biotech shares how his company was able to reach a partnership with Rani so quickly and why it is confident in its GLP-1/GLP-2 dual agonist for obesity and diabetes, despite recent disappointing clinical results for its sole rival.

Metabolic Disorders Research & Development

Parexel Execs On Obesity, AI And Data Trends

Parexel’s chief strategy officer Kushal Gohil, clinical EVP Stephen Pyke and India head Sanjay Vyas share thoughts on possible hurdles to, and the cascading impact of obesity treatments, GenAI progress and the opportunities and challenges of real-world data in India.

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Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

Rare Diseases Drug Approval Standards
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