Excipient GMP Quality Standards: One is Enough

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.

A capsule formulation may offer more consistent and reliable uptake versus a syringe, while being less dependent on food intake.

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

Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.

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