Ipsen re­ceives new palo­varotene PDU­FA date; Ac­er halts de­vel­op­ment of ex-Sanofi drug

The FDA will be giv­ing Ipsen an­oth­er shot at ap­proval for one of its can­di­dates.

Ipsen an­nounced that the FDA has set the PDU­FA date for Aug. 16, 2023, as more in­for­ma­tion on palo­varotene’s clin­i­cal tri­al will be in­clud­ed in the re­sub­mis­sion. This com­pris­es more analy­ses across the clin­i­cal tri­al pro­gram, in­clud­ing the first Phase III study that was car­ried out in pa­tients with fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va, or FOP.

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