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Home » Topics » Regulatory

Regulatory
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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

FDA approves Stivarga for second-line treatment of hepatocellular carcinoma

April 28, 2017

FDA approves Brineura to treat CLN2 disease

April 28, 2017

FDA grants accelerated approval to Tecentriq for bladder cancer not treatable with cisplatin

April 18, 2017

FDA grants approval for Ingrezza capsules for adults with tardive dyskinesia

April 12, 2017

FDA approves Austedo to treat chorea associated with Huntington's disease

April 4, 2017

European Commission approves Tafinlar with Mekinist for BRAF V600-positive NSCLC

April 3, 2017
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