Global declaration from July 27 to July 31, 2015

1 Approval of new drugs 1 On July 30, 2015, the European Union approved the use of abelvidamumumab in the treatment of suppurative sweat gland inflammation 2 Recognition of breakthrough therapy 1 On July 28, 2015, the FDA awarded Progenics azedra the recognition of breakthrough therapy for pheochromocytoma and paraganglioma 2 On July 29, 2015, the FDA awarded weisulovatinib as a breakthrough treatment for renal cell carcinoma 3 Priority review 1 On July 28, 2015, FDA accepted the listing application of Merck grazoprevir / elbasvir for treatment of type 1, 4, 6 HCV, and granted the priority review qualification, PDUFA date: January 28, 2016 Four, the listing application and review 1.2015 years July 27th news, Adapt submitted to the FDA Narcan (naloxone hydrochloride nasal spray) listing application, the drug has entered the FDA fast track, FDA will decide whether to accept the application within 60 days 2 On July 28, 2015, EMA accepted the MAA application of Teva reslizumab for asthma treatment 3 On July 28, 2015, FDA accepted the application of CSL rviii single chain (LO noctocog alfa) for hemophilia A bla 4 On July 29, 2015, FDA accepted the listing application of ZS Pharma hyperkalemia drug zs-9, PDUFA date: May 26, 2016 5 On July 29, 2015, FDA accepted the listing application for the treatment of secondary hyperparathyroidism by rayaldee, a sustained-release capsule of opko 6 On July 30, 2015, Weicai submitted the listing application of aribrin mesylate for sarcoma treatment in the United States, Europe and Japan 7 On July 31, 2015, amda submitted an application for ri-002 to FDA for the treatment of BLA 5 Clinical progress 1 On July 27, 2015, FDA approved the application of fibrogen fg-3019 for the treatment of pseudohypertrophic muscular dystrophy ind 2 On July 29, 2015, FDA approved the application of ignyta rxdx-107 for solid tumor ind 3 On July 29, 2015, FDA approved KaloBios kb-003 application for the treatment of ind 4 On July 30, 2015, FDA approved Juno jcar-015 application for the treatment of adult relapsed refractory acute lymphoblastic leukemia ind.