[REVISION HISTORY]
Pharmaceutical industry regulatory and corporate activity
Updated 1 time since CLSTR started tracking revisions of this situation.
What changed
2026-09-18 22:22 UTC → 2026-09-22 06:06 UTC ·
added
removed
The pharmaceutical sector has experienced significant regulatory and corporate developments. The FDA approved Fayuvi (rebisufligene etisparvovec-hopf), developed by Ultragenyx Pharmaceuticals, marking the first approved treatment for Sanfilippo syndrome Type A. This one-time gene therapy, originally developed by Abeona Therapeutics, is priced at $3.95 million in the US. Following this approval, Andelyn Biosciences has commenced commercial manufacturing of Fayuvi at its facility in Columbus, Ohio. This marks the first FDA-approved gene therapy to be produced using the ‘Andelyn AAV Curator Platform’ process. Manufacturing is also occurring at Ultragenyx’s facility in Bedford, Massachusetts. In addition to this approval, these developments, the industry saw corporate activity including Lisata Therapeutics’ acquisition of Marea Therapeutics and a partnership between mAbxience and Sandoz to commercialize an emicizumab biosimilar. Discussions regarding drug policy also emerged, with advocates for the Pharmaceutical Reform Alliance calling for the codification of Most-Favored-Nation pricing to manage costs.
Versions
- 2026-09-22 06:06 UTC Pharmaceutical industry regulatory and corporate activity
- 2026-09-18 22:22 UTC Pharmaceutical industry regulatory and corporate activity
Only revisions since CLSTR began indexing content versions appear here. Select a version to see what changed compared to the one before it.