Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.
US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat following the European Medicines Agency (EMA) regulatory submission acceptance and approval of Duvroq in Japan
- Read more about FDA accepts New Drug Application for daprodustat of GSK
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source https://www.pharmatutor.org/pharma-news/2022/fda-accepts-new-drug-application-for-daprodustat-of-gsk
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