Ascendis Pharma announced the submission of a MAA to the EMA seeking approval for TransCon hGH (lonapegsomatropin), an investigational long-acting once-weekly prodrug of somatropin (human growth hormone or hGH), previously known as ACP 001, for the treatment of pediatric patients who are diagnosed with growth hormone deficiency (GHD).
r-hGH is administered by subcutaneous injection or needle free transjection, once daily. Depending on the brand, injections may be prepared...
Ascendis Pharma A/S announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization for Lonapegsomatropin Ascendis Pharma (TransCon hGH).
Ascendis Pharma A/S announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin. Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD).
Opko Health Inc. and Pfizer Inc. announced that they have entered into a worldwide agreement for the development and commercialization...
Ascendis Pharma announced preliminary results from the phase III fliGHt Trial of TransCon Growth Hormone (hGH). The results indicated treatment...
Ascendis Pharma A/S has announced positive top-line results from the phase III heiGHt Trial a randomized, open-label, active-controlled trial that...
Ascendis Pharma announced that the FDA has approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
OPKO Health, Inc. has completed enrollment in the Company’s global pivotal Phase III study in growth hormone deficient children, evaluating...
Phase III results were announced of 24 months efficacy and safety in children with Growth Hormone Deficiency (GHD) for LB...