Minaris and Genetix Biotherapeutics Expand Manufacturing Partnership to Support Commercial Supply for LYFGENIA™ (lovotibeglogene autotemcel)

Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality ...

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.
BioSpace

FDA Carves Out Manufacturing Exemptions for CGTs to Accelerate Development

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
pharmaphorum

FDA removes barriers to cell, gene therapy development

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...