FDA hands off its lat­est whirl­wind drug OK as Hori­zon hus­tles would-be block­buster to the mar­ket

The FDA isn’t let­ting its foot off the gas ped­al just be­cause it’s Jan­u­ary.

The agency came through with an ap­proval for Hori­zon Ther­a­peu­tics’ $HZNP new thy­roid eye drug Te­pez­za (tepro­tu­mum­ab), close to two months ahead of the PDU­FA date — which was al­ready set ear­ly in the year due to a pri­or­i­ty re­view des­ig­na­tion. But that sort of thing is be­com­ing rou­tine at the agency, es­pe­cial­ly if it has a des­ig­nat­ed “break­through ther­a­py” on its hands.

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