FDA Faces Multiple Challenges

Seladelpar, which is marketed in the US as Livdelzi, was recommended for an orphan drug designation by CHMP in December 2024.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The agency has received certification with the Eco-Management and Audit Scheme for its commitment to environmental sustainability.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

The pledge signifies ArisGlobal’s commitment to upholding high standards and best practices for the responsible use of artificial intelligence.

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.