Resources, Guidelines, and Guidance Documents Directory

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

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

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

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

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.