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BioWorld - Monday, February 9, 2026
Home » Topics » Regulatory

Regulatory
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FDA approves Orkambi for younger cystic fibrosis population

Sep. 29, 2016

FDA approves Rexulti labeling update for maintenance treatment of schizophrenia

Sep. 26, 2016

FDA approves adalimumab biosimilar Amjevita

Sep. 26, 2016

FDA grants accelerated approval to Exondys 51 for Duchenne muscular dystrophy

Sep. 20, 2016

FDA approves Aralez Pharmaceuticals' Yosprala

Sep. 16, 2016

Opdivo intravenous infusion approved in Japan for treatment of unresectable or metastatic RCC

Sep. 8, 2016

FDA approves Blincyto for pediatric patients with Ph-negative B-cell precursor ALL

Sep. 2, 2016

European Commission approves Pfizer's crizotinib for ROS-1 positive NSCLC

Sep. 1, 2016

FDA approves biosimilar etanercept Erelzi

Aug. 31, 2016

Hemispherx Biopharma's NDA for rintatolimod receives approval in Argentina

Aug. 24, 2016
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