Ascendis Pharma submits candidate for US market approval
Transcon PTH has been granted the orphan drug designation by both the US and EU, and the drug is now ready for an FDA review.
by christian bundgaard, translated by daniel pedersen
Following two successful phase III studies of drug candidate Transcon PTH against hypoparathyroidism, a disease that can cause muscle cramps or pains due to the body producing low levels of the parathyroid hormone, or PTH, and calcium, Ascendis Pharma now feels prepared to seek US approval.
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