FDA cites ‘deficiencies’ in Ascendis’ application for parathyroid drug, jeopardizing potential approval

FDA cites ‘deficiencies’ in Ascendis’ application for parathyroid drug, jeopardizing potential approval

Source: 
Endpoints
snippet: 

The FDA is asking for more information about Ascendis Pharma’s drug for hypoparathyroidism, a rare condition in which the body doesn’t produce enough of a key hormone for regulating calcium.