Keeping Track: New Submissions In Bladder Cancer, HCV And Diabetes; Avastin Label Expands
The latest drug development news and highlights from our FDA Performance Tracker.
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Keeping Track Of Novel Agents: US FDA Approves Nerlynx And Vosevi, Turns Down Evenity; Macrilen Returns
News and highlights about novel agents from our FDA Performance Tracker.
Highly positive top-line weight loss results for Novo Nordisk's new GLP-1 agonist semaglutide are propelling it into Phase III trials next year for the notoriously tricky indication. The product is currently under review for type 2 diabetes.
Indian generic giant Sun Pharma says the US FDA has flagged up new potential violations of good manufacturing practices at the company's key Halol factory, which exports a large number of products to the crucial US market and had been expected to overcome its past compliance problems.