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 ...
Ascendis Pharma's supplemental application for SKYTROFA in adult GHD has been accepted by the FDA, aiming for broader patient access. Acceptance of the sBLA does not guarantee approval; the company ...
Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth hormone deficiency, or GHD, for TransCon hGH. The FDA set ...
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