The U.S. Food and Drug Administration (FDA) announced it has cleared radiopharmaceutical developer Navidea Biopharmaceuticals' Lymphoseek diagnostic imaging agent.
Lymphoseek (technetium-99m tilmanocept) injection helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes, according to the FDA.
In its notice, the FDA specified that Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging agent. It is the first new drug for lymph-node mapping approved by the agency in more than 30 years, the FDA said.
