Myovant Ready To File Relugolix For Prostate Cancer
Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.
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The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.
Cadila Healthcare has launched a generic version of Astellas/Pfizer’s prostate cancer therapy Xtandi in India at a sharp discount of 70-90% to existing brands and hopes the lower financial burden on patients will aid adherence.
Keeping Track Of Submissions: Myovant’s First Relugolix NDA; Merck Resubmits Longer Keytruda Dosing; Biogen Adjusts Aducanumab Rolling Target
The latest news and highlights about submissions for US approval, from the Pink Sheet FDA Performance Tracker.