FDA rejects Ascendis Pharma drug

The FDA first expressed concerns over shortcomings in the company’s market authorization application, and is now declining to clear the hypoparathyroidism treatment.

by mikkel aabenhus hemmingsen, translated by daniel pedersen

In a not-so-unexpected turn of events, the US Food and Drug Administration (FDA) has rejected drugmaker Ascendis Pharma’s TransCon PTH and its related device.

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