- 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 key trial in children with rare liver diseaseIpsen disclosed that Bylvay failed a Phase 3 study for biliary atresia, a serious liver disease that leads the bile ducts to become blocked in babies. Babies with the disease can get a Kasai proced…Endpoints · 4d ago↗ source