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Home » Topics » Regulatory

Regulatory
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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

FDA approves Pfizer's Troxyca ER

Aug. 22, 2016

Will biosimilar carve-outs put R&D for older MAbs on ice?

Aug. 11, 2016
By Mari Serebrov
Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...
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