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Home » Topics » Regulatory

Regulatory
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FDA approves infant-specific dose of Pertzye

Oct. 13, 2016

FDA approves Carnexiv as intravenous short-term replacement therapy for seizures

Oct. 10, 2016

Micatrio approved in Japan for hypertension

Oct. 3, 2016

Mikeluna approved in Japan for glaucoma and intraocular hypertension

Sep. 30, 2016

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
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