Navidea announces priority review for sNDA to expand Lymphoseek labeling Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has accepted the Supplemental New Drug Application and granted a Priority Review for the expanded use of Lymphoseek Injection indicated for sentinel lymph node detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act, the FDA has set a target review date for the Lymphoseek sNDA of June 16. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
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Navidea price target raised to $5 from $3 at JMP Securities JMP Securities increased its price target on Navidea after the company reported higher than expected Q2 Lymphoseek sales and operating income. The firm thinks the company has a number of significant growth drivers and keeps an Outperform rating on the shares.