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BioWorld - Wednesday, April 15, 2026
Home » Topics » Regulatory

Regulatory
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FDA approves Luxturna gene therapy for biallelic RPE65 mutation-associated retinal dystrophy

Dec. 20, 2017

FDA approves Pfizer's infliximab biosimilar Ixifi

Dec. 14, 2017

New formulation of Oncaspar approved in Europe

Dec. 14, 2017

FDA approves Nucala for the treatment of eosinophilic granulomatosis with polyangiitis

Dec. 13, 2017

FDA approves Novo Nordisk's Ozempic for type 2 diabetes

Dec. 7, 2017

FDA approves Repatha to prevent heart attack and stroke, and to lower LDL-C

Dec. 4, 2017

FDA approves Isentress for the treatment of HIV-1 infection in newborns weighing at least 2 kg

Dec. 4, 2017

Companion diagnostics 'Foundation' forever changed with FDA approval

Dec. 4, 2017
By Omar Ford
Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.
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FDA approves Juluca, the first two-drug regimen for treatment of HIV-1

Nov. 22, 2017

European Commission approves trastuzumab biosimilar Ontruzant

Nov. 20, 2017
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