[ad_1] Ascendis Pharma • Third Quarter financial results and business update conference call to be held onNovember 7, 2023 • Resubmission of TransCon PTH NDA for adults with hypoparathyroidism expected…
Tag: PTH
Ascendis Pharma Receives Positive CHMP Opinion for TransCon™ PTH (palopegteriparatide) for Adults with Chronic Hypoparathyroidism
[ad_1] – Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union launch planned in Germany in early 2024 COPENHAGEN, Denmark, Sept. 14, 2023…
Ascendis Pharma Opens Compassionate Use Program for TransCon™ PTH (palopegteriparatide) in Germany
[ad_1] Ascendis Pharma Opens Compassionate Use Program for … Kentucky Today [ad_2] Source link
U.S. Food & Drug Administration Issues Complete Response Letter for TransCon™ PTH in Hypoparathyroidism | BioSpace
[ad_1] FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product No new preclinical studies, or Phase…
U.S. Food & Drug Administration Issues Complete Response Letter for TransCon™ PTH in Hypoparathyroidism
[ad_1] Ascendis Pharma FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product No new preclinical studies, or Phase…