Ascendis Pharma bags YORVIPATH FDA approval for adult hypoparathyroidism

Ascendis Pharma bags YORVIPATH FDA approval for adult hypoparathyroidism

In a landmark decision, the U.S. Food and Drug Administration (FDA) has granted approval to Ascendis Pharma A/S’s YORVIPATH (palopegteriparatide), making it the first and only treatment specifically for adult hypoparathyroidism. This rare endocrine disorder, characterised by insufficient levels of parathyroid hormone, affects between 70,000 to 90,000 people across the United States. YORVIPATH, developed under […]

FDA accepts Ascendis Pharma’s TransCon hGH BLA for pediatric GHD

FDA accepts Ascendis Pharma’s TransCon hGH BLA for pediatric GHD

Ascendis Pharma, a Danish biopharma company, said that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TransCon hGH (lonapegsomatropin) for the treatment for pediatric growth hormone deficiency (GHD). TransCon hGH is an investigational long-acting prodrug of somatropin (human growth hormone or hGH). The FDA has set a Prescription […]