Two gene ther­a­py ap­provals head­line CBER’s FY 2018 re­port

The FDA Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) on Wednes­day pub­lished its fis­cal year 2018 re­port, high­light­ing two gene ther­a­py ap­provals, as well as the ap­provals of a he­pati­tis B vac­cine, a vac­cine to pre­vent shin­gles and a flu vac­cine for chil­dren as young as six months.

Both of the gene ther­a­py ap­provals oc­curred at the very be­gin­ning of the pre­vi­ous fis­cal year, with CBER sign­ing off on Spark Ther­a­peu­tics’ Lux­tur­na (voreti­gene nepar­vovec-rzyl) for chil­dren and adult pa­tients with an in­her­it­ed form of vi­sion loss in De­cem­ber 2017 and Gilead’s Yescar­ta (axi­cab­ta­gene ciloleu­cel), a cell-based gene ther­a­py, to treat adult pa­tients with cer­tain types of large B-cell lym­phoma, in Oc­to­ber 2017.

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