FDA push­es back As­cendis' PDU­FA for long-act­ing hor­mone ther­a­py; De­bio­pharm takes home a win in mid-stage test for ADC

Dan­ish biotech As­cendis Bio­phar­ma has been work­ing on a treat­ment for pe­di­atric growth hor­mone de­fi­cien­cy, but the FDA says they’re go­ing to have to wait a lit­tle bit longer be­fore they can make their ap­proval de­ci­sion.

Reg­u­la­tors ex­tend­ed the re­view pe­ri­od by three months on Mon­day, As­cendis said, push­ing back the PDU­FA date to Sep­tem­ber 25. The ex­ten­sion was in re­sponse to ad­di­tion­al in­for­ma­tion As­cendis sub­mit­ted as part of its BLA.

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