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批准类型 药品名称 活性成分 适应症 上市发布公告 临床试验快照 批准日期 申请机构
NME Egaten triclabendazole To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes” Drug Trials Snapshot 2019/02/13 NOVARTIS PHARMS CORP
Biologics Cablivi caplacizumab-yhdp To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) Press Release Drug Trials Snapshot 2019/02/06 ABLYNX NV
Biologics JEUVEAU PRABOTULINUMTOXINA-XVFS For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients Drug Trials Snapshot 2019/02/01 EVOLUS INC
Biologics Ultomiris ravulizumab To treat paroxysmal nocturnal hemoglobinuria (PNH) Press Release Drug Trials Snapshot 2018/12/21 ALEXION PHARM
Biologics Elzonris tagraxofusp-erzs To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) Press Release Drug Trials Snapshot 2018/12/21 STEMLINE THERAPEEUTICS INC
Biologics Asparlas calaspargase pegol-mknl To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years Drug Trials Snapshot 2018/12/20 SERVIER PHARMA LLC
NME Motegrity prucalopride To treat chronic idiopathic constipation Drug Trials Snapshot 2018/12/14 SHIRE DEV LLC
NME Xospata gilteritinib To treat patients who have relapsed or refractory acute myeloid leukemia (AML) Press Release 2018/11/28 ASTELLAS
NME Firdapse amifampridine To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults Press Release 2018/11/28 CATALYST PHARMA INC
NME Vitrakvi larotrectinib To treat patients whose cancers have a specific genetic feature (biomarker) Press Release 2018/11/26 LOXO ONCOLOGY INC
NME Daurismo glasdegib To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients Press Release 2018/11/21 PFIZER INC
Biologics Gamifant emapalumab-lzsg To treat primary hemophagocytic lymphohistiocytosis (HLH) Press Release 2018/11/20 NOVIMMUNE S.A.
NME Aemcolo rifamycin To treat travelers’ diarrhea Press Release Drug Trials Snapshot 2018/11/16 COSMO TECHNOLOGIES LTD
NME Yupelri revefenacin To treat patients with chronic obstructive pulmonary disease (COPD) Drug Trials Snapshot 2018/11/08 THERAVANCE BIOPHARMA
NME Lorbrena loratinib To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer 2018/11/02 PFIZER INC
NME Xofluza baloxavir marboxil For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. Press Release Drug Trials Snapshot 2018/10/24 SHIONOGI INC
NME Talzenna talazoparib For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation. Drug Trials Snapshot 2018/10/16 PFIZER INC
NME Tegsedi inotersen To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults Drug Trials Snapshot 2018/10/05 IONIS PHARMS INC
Biologics Revcovi elapegademase-lvlr To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) Drug Trials Snapshot 2018/10/05 LEADIANT BIOSCI INC
NME Nuzyra omadacycline To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections Drug Trials Snapshot 2018/10/03 PARATEK PHARMS INC