Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Danish Pharma firm Ascendis Pharma announced the European Commission approval for palopegteriparatide (Yorvipath), for treatment of Adults with Chronic Hypoparathyroidism. Earlier in April 23, USFDA had declined to approve the hormone disorder therapy citing concerns linked to manufacturing control of the drug and device combination. However in Sep 2023 Committee for Medicinal Products for Human Use (CHMP), Europe had adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yorvipath
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