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European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva Decision follows negative opinion by the Committee for Medicinal...
European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva (FOP)Decision...
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the...
Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placebo Elafibranor was well tolerated with a safety profile consistent with previous studies Resu...
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...