FDA increases manufacturing flexibility for cell and gene therapies
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
Cytiva Navigating cell therapy WP 4
Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis
Alternative commercialisation models offer lifeline to future of gene therapies
Cell and gene therapy investment strategy pivots as funding dries up
Solid Biosciences’ SGT-212 gains FDA rare paediatric disease status
Regeneron and Tessera join forces to forge in vivo AATD gene therapy
Potentially “groundbreaking” FDA gene therapy pathway leaves key issues unresolved
IASO Bio gains Hong Kong approval for Fucaso application
