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BioWorld - Thursday, March 12, 2026
Home » Topics » Regulatory

Regulatory
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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

FDA approves Daurismo for newly diagnosed AML ineligible for intensive chemotherapy

Nov. 22, 2018

FDA grants accelerated approval to Venclexta for newly diagnosed AML

Nov. 22, 2018
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