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- Amgen submits new analysis to FDA to defend continued availability of TavneosAmgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
- Ipsen's Bylvay fails Phase 3 trial in children with biliary atresiaIpsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…