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- EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech ActThe European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
- FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocelDuring an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…