source
- Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concernsAmgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
- 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…