ARTICLE | Clinical News

Lymphoseek tilmanocept regulatory update

September 22, 2014 7:00 AM UTC

Navidea said FDA granted Orphan Drug status for Lymphoseek tilmanocept to detect sentinel lymph nodes in patients with cancer of the head and neck. In June, FDA approved an sNDA for the product for sentinel lymph node detection in patients with squamous cell carcinoma of the head and neck (SCCHN). Another sNDA for Lymphoseek is under FDA review to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities, with an Oct. 16 PDUFA date. ...