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Series of JAK inhibitor delays may signal an upcoming FDA adcomm – Endpoints News

Three-month review delays from the FDA have become the norm in recent days for JAK inhibitors, some of which are seeking label expansions. But the pushback of these…



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Three-month re­view de­lays from the FDA have be­come the norm in re­cent days for JAK in­hibitors, some of which are seek­ing la­bel ex­pan­sions.
But the push­back of these ac­tion dates for Ab­b­Vie’s Rin­voq, Pfiz­er’s Xel­janz and abroc­i­tinib, and Eli Lil­ly’s Olu­mi­ant may be a sign that the FDA is prepar­ing to hold an ad­vi­so­ry com­mit­tee of out­side ex­perts to re­view the risk/ben­e­fit pro­files of JAK in­hibitors for atopic der­mati­tis, ac­cord­ing to Leerink an­a­lyst Ge­of­frey…

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