Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily, Oral Relugolix for the Treatment of Men with Advanced Prostate Cancer
Myovant Sciences Ltd. Common Shares (MYOV)
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Source: GlobeNewswire
Positive Phase 3 results with 96.7% response rate in men with advanced prostate cancer form the basis of the submissionMyovant expects to submit a second NDA for relugolix combination tablet for women with uterine fibroids in May 2020 BASEL, Switzerland, April 21, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women's health and prostate cancer, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. Myovant also announced that it expects to submit its NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids in May 2020. TWEET THIS: “The submission of our NDA for prostate cancer is a major step towards providing a one pill, once a d
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