New Breast Cancer Product Approval and Upcoming Workshop

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Title: New Breast Cancer Product Approval and Upcoming Workshop
Office of Women's Health, FDA

March 2013
http://www.fda.gov/womens

Recent Women's Health News

FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers

Today FDA approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

View the press release.

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FDA Public Workshop: Innovations in Breast Cancer Drug Development

FDA is co-sponsoring a public workshop on March 22, 2013 to discuss issues related to breast cancer drug development in neoadjuvant trials.  The discussions at this workshop will be taken into consideration as the FDA moves to finalize the Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.

Register and view the workshop information.

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New Consumer Update on Women’s Health

FDA has launched a new series of consumer updates that will highlight women’s health topics throughout the year. The first article features an interview with Marsha Henderson – Assistant Commissioner for Women’s Health at FDA.

Read more about how the FDA works to protect and promote the health of women.


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