FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but en­sured af­ter an over­whelm­ing­ly neg­a­tive ad­comm vote this Sep­tem­ber, the FDA is yank­ing On­copep­tides’ dan­gling ac­cel­er­at­ed ap­proval. And there may be more to come.

In re­cent months, US reg­u­la­tors have honed in on re­form­ing the ac­cel­er­at­ed ap­proval path­way and pre­vent­ing drug­mak­ers from con­tin­u­ing to sell their med­i­cines in the event of a con­fir­ma­to­ry study flop. The moves come af­ter com­mis­sion­er Rob Califf has called for com­pa­nies to do more to pro­duce post-mar­ket­ing ev­i­dence quick­ly ear­li­er this year.

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