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Home » Topics » Regulatory

Regulatory
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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.
Read More

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

FDA first to approve Hemlibra for hemophilia A

Nov. 17, 2017

FDA approves Mepsevii for mucopolysaccharidosis type VII

Nov. 16, 2017

FDA approves Heplisav-B for prevention of hepatitis B in adults

Nov. 10, 2017

FDA approves Adcetris in new indication

Nov. 10, 2017

FDA approves Prevymis for CMV prevention in adult HSCT recipients

Nov. 9, 2017
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