Trick, or treat? FDA plans Hal­loween ad­comm for Ipsen’s sec­ond chance at rare dis­ease drug

An oft-ma­ligned rare bone dis­ease pro­gram at Ipsen is go­ing to get a clos­er look from reg­u­la­tors on a day that’s proven to be mighty spooky.

The FDA has sched­uled an ad­vi­so­ry com­mit­tee to ex­am­ine Ipsen’s palo­varotene on Oct. 31, ac­cord­ing to a no­tice post­ed in the Fed­er­al Reg­is­ter, set­ting up a show­down for a drug that once failed a Phase III test. The hear­ing will come about two months ahead of palo­varotene’s de­ci­sion date, which is slat­ed for Dec. 29.

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