FDA Review Extension of BLA for Orca-T for the Treatment of Heme Malignancies
“We appreciate the frequent engagement with the FDA throughout the review process,” said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. “Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible.”
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