Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men
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Erleada is ninth product known to be using US FDA’s Real-Time Oncology Review pilot program, as shown in our comprehensive chart.
Amgen's Evenity Faces CV Safety Gauntlet At US FDA Advisory Cmte.
Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.