FDA接受Transcon GH的Ascendis sBLA

Ascendis Pharma (ASND) said the FDA has accepted for its supplemental Biologics License Application for TransCon hGH for the treatment of adult growth hormone deficiency, or GHD.

The agency has set a target action date for the application of July 27, 2025.

The Danish drugmaker already markets the therapy for pediatric GHD under the name Skytrofa.