Mainland China’s regulatory evolution brings greater access to novel drugs
Clarivate
MAY 11, 2023
However, to gain approval for a new drug or label expansion, developers needed to meet specific requirements laid out by the CDE. Hemophagocytic lymphohistiocytosis (HLH) Emapalumab Gamifant Swedish Orphan Biovitrum AB 2022 Patients with refractory or relapsed HLH HLH is an extremely rare, highly progressive hyperinflammatory disorder.
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