Zealand Pharma' NDA for glepaglutide gets US FDA complete response letter for treatment ...

Zealand Pharma announced the FDA issued a complete response letter for its NDA for glepaglutide, a GLP-2 analog for short bowel syndrome with intestinal failure. The FDA recommended an additional trial for efficacy and safety confirmation. Zealand Pharma remains committed to regulatory approval and plans a European MAA submission in 2025.


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Zealand Pharma' NDA for glepaglutide gets US FDA complete response letter for treatment ...

Zealand Pharma announced the FDA issued a complete response letter for its NDA for glepaglutide, a GLP-2 analog for short bowel syndrome with intestinal failure. The FDA recommended an additional trial for efficacy and safety confirmation. Zealand Pharma remains committed to regulatory approval and plans a European MAA submission in 2025.

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