Novartis-backed Gamida Cell grabs a breakthrough trophy for experimental cell treatment
Israel’s Gamida Cell is getting flagged to the inside regulatory track at the FDA. The agency has handed the company – which includes Novartis as a prominent investor – its breakthrough drug designation for a top product in development, intended to provide an open door to the agency to help speed along the approval process.
BTDs are becoming quite common at the FDA. And this time its special status is being applied to NiCord, which is being developed as a replacement for bone marrow transplants.
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