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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