[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…
Tag: Hypoparathyroidism
Recon: FDA declines to approve Ascendis’ hypoparathyroidism drug; Astellas to buy Iveric for $5.9B
[ad_1] Recon | 01 May 2023 | By Joanne S. Eglovitch Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA advisory committee votes against plan…
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…