A Prescription Drug User Fee Act target date of July 27, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License ...
ADULT human skin has been successfully cultured ... on glass surfaces may assume a pavement-like appearance and mimic the growth pattern of epithelial cells 1. To avoid this, several investigators ...
The FDA has accepted Ascendis Pharma's supplemental Biologics License Application for TransCon hGH in adult growth hormone deficiency, marking a significant step toward expanding its market and ...
This revised edition reviews the substantial advances in our understanding of the vital role of growth hormone (GH) in maintaining adult health, and the disorders that result from GH deficiency. The ...
The sBLA submission is based on results from foresiGHt, a phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial that compared the efficacy and ...