IPSEY - New FDA action date in August for Ipsen bone disease drug palovarotene
2023-03-16 17:44:59 ET
- The US FDA has set August 16 as the new action date for Ipsen's ( OTCPK:IPSEY ) resubmitted New Drug Application for palovarotene for fibrodysplasia ossificans progressiva.
- In December 2022, the French pharma received a Complete Response Letter from the agency requesting additional information.
- A European Medicines Agency advisory committee declined to recommend approval of Ipsen's ( OTCPK:IPSEF ) candidate in January.
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New FDA action date in August for Ipsen bone disease drug palovarotene