Ipsen announces European Commission decision on
European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva (FOP)Decision...
Source: globenewswire.com
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Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE® trial of elafibranor in patients with primary biliary cholangitis, a rare cholestatic liver disease - Ipsen (OTC:IPSEY)
Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placeboElafibranor was well tolerated with a safety profile
Source: benzinga.com
Ipsen announces positive outcome of FDA Advisory Committee
Advisory committee voted 10 for and 4 against that evidence from the Phase III MOVE study show palovarotene is an effective treatment in patients with the...
Source: globenewswire.com
FDA Panel Votes on Palovarotene for Fibrodysplasia Ossificans Progressiva
An FDA committee voted favorably on whether the available evidence supports the effectiveness of palovarotene for fibrodysplasia ossificans progressiva.
Source: empr.com
U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome
Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial... | June 13, 2023
Source: marketscreener.com