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BioWorld - Tuesday, December 23, 2025
Home » Topics » Regulatory

Regulatory
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FDA grants accelerated approval to Venclexta for newly diagnosed AML

Nov. 22, 2018

FDA approves Gamifant for primary hemophagocytic lymphohistiocytosis

Nov. 21, 2018

FDA approves Aemcolo for the treatment of travelers' diarrhea

Nov. 19, 2018

FDA grants approval for Adcetris as first-line treatment for peripheral T-cell lymphoma

Nov. 19, 2018

European Commission approves Cabometyx for HCC previously treated with sorafenib

Nov. 15, 2018

FDA approves Yupelri for maintenance treatment of COPD

Nov. 12, 2018

European Commission approves expanded label for Trelegy Ellipta in COPD

Nov. 9, 2018

FDA approves Bijuva for moderate to severe hot flashes due to menopause

Oct. 30, 2018

France becomes first country to market baclofen preparation to reduce alcohol consumption

Oct. 29, 2018

FDA approves Dupixent as add-on maintenance therapy for asthma

Oct. 22, 2018
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