NDA Submission

Ascendis Seeks FDA Nod For TransCon PTH In Adults With Hypoparathyroidism

Ascendis Pharma (NASDAQ: ASND) has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon PTH, an investigational pro-drug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism.

Minerva Seeks FDA Approval For Schizophrenia Candidate

Minerva Neurosciences (NASDAQ: NERV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone in the treatment of negative symptoms for patients with schizophrenia.