Content matching 'Investigational New Drug'
Cell therapy weekly: FDA indicates more guidance is to come on cell therapy manufacture
Researchers received the go-ahead from the FDA to test a gene-editing technique in humans and produce a "functional cure" for HIV.
Cell therapy weekly: FDA issues statement marking halfway point in enforcement period for unproven regenerative medicine therapies
Cell therapy weekly: StemGenex receives warning letter from FDA over unapproved cell therapy and facility with “significant violations”
Cell therapy weekly: Severe spinal cord injury trial demonstrates favorable safety and improved motor function