Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug ...
Streamlined Regulatory Pathway: The GMP PSXi013 iPSC line will be supported by a Drug Master File (DMF) submission to the US FDA to simplify the Investigational New Drug (IND) application process ...