UPDATE 1-U.S. FDA grants accelerated approval for Immunomedics' breast cancer therapy [Reuters]
IMMUNOMEDICS (IMMU)
Last immunomedics earnings: 2/27 04:00 pm
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US:NASDAQ Investor Relations:
immunomedics.com/2017/immunomedics-announces-presentations-investor-event-2017-san-antonio-breast-cancer-symposium
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Source: Reuters
UPDATE 1-U.S. FDA grants accelerated approval for Immunomedics' breast cancer therapy (adds background on therapy, statistics on breast cancer) April 22 (Reuters) - Immunomedics Inc won an accelerated approval from the U.S. Food and Drug Administration for Trodelvy, its therapy for a form of invasive breast cancer that has worsened despite two prior rounds of treatment, the company said on Wednesday. Trodelvy injection, approved to treat metastatic triple-negative breast cancer, comes with a boxed warning – the FDA's harshest – that flags risks of severe diarrhea and neutropenia, an abnormally low count of a type of white blood cell. ( bit.ly/2XW5G3z ) The therapy’s label specified that its continued approval may depend upon verification of clinical benefit in supporting trials. The FDA had declined to grant accelerated approval for the breast cancer therapy in January last year here Patients with triple-negative breast cancer test negative for hormone receptors or HER2, meaning thei
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