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Home » Topics » Regulatory

Regulatory
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FDA grants early approval for Ultomiris for the treatment of adults with PNH

Dec. 24, 2018

Elzonris receives FDA approval for the treatment of blastic plasmacytoid dendritic cell neoplasm

Dec. 24, 2018

Toripalimab first domestically produced anti-PD-1 MAb approved in China

Dec. 20, 2018

China becomes first country to approve roxadustat

Dec. 18, 2018

Aplidin approved in Australia for the treatment of multiple myeloma

Dec. 12, 2018

FDA approves Dextenza intracanalicular insert to treat postsurgical ocular pain

Dec. 3, 2018

Precedex approved for use in pediatric patients in Japan

Nov. 30, 2018

Melinta Therapeutics granted marketing authorization for Vabomere in Europe

Nov. 28, 2018

FDA grants accelerated approval to Vitrakvi for advanced solid tumors with NTRK gene fusion

Nov. 27, 2018

European Commission approves pegfilgrastim biosimilar Pelmeg

Nov. 26, 2018
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