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BioWorld - Monday, December 15, 2025
Home » Topics » Regulatory

Regulatory
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FDA grants accelerated approval to Keytruda and priority review for further indication

May 24, 2017

FDA approves Actemra as first therapy to treat giant cell arteritis

May 23, 2017

FDA approves Keytruda for certain patients with locally advanced or metastatic urothelial carcinoma

May 19, 2017

European Commission approves dinutuximab beta for the treatment of high-risk neuroblastoma

May 11, 2017

FDA approves Bavencio for advanced urothelial carcinoma

May 10, 2017

FDA approves Kisqali Femara Co-Pack

May 10, 2017

FDA approves Tymlos for postmenopausal women with osteoporosis at high risk for fracture

May 3, 2017

FDA grants accelerated approval to Alunbrig for ALK-positive NSCLC

May 2, 2017

FDA approves Rydapt for patients with newly diagnosed AML with FLT3 mutation

May 2, 2017

FDA grants accelerated approval to Imfinzi for previously treated bladder cancer

May 2, 2017
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