Tag: Investigational New Drug

FDA Predicts Rapid Development of Cell and Gene Therapies

A massive upsurge in the development of cell and gene therapies means the FDA expects to receive up to 200 applications to start trials every year from 2020. It also expects to be approving 10 to 2...

FDA Recommendations for Submitting Human Gene Therapeutic IND Application

Human therapeutics include all products that transmit and unfold their effect through transcription or translation of transferred genetic material or through targeted modification of host/human gene s...

FDA Cleared the IND Application of BBT-877

Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the Investigational New Drug (I...