Tag: gene therapies
Accelerating Biologics R&D with Unified Software and Data Flows
Biologics are changing the way we treat disease, affecting where companies invest, and, most importantly, impacting patients’ lives. Last year, nearly half of the 37 new drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) were biologics, while its partner agency—the U.S. [1] Center for Biologics Evaluation and Research (CBER)—approved a dozen additional products. [2] These approvals span many modalities and cover a range of conditions, including many rare and hard-to-treat diseases.
Magenta Therapeutics Confirms IND Clearance for MGTA-117; Expects to Open Phase...
Boston-based Magenta Therapeutics confirmed that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for MGTA-117 in Acute...