Keeping Track Of Novel Agents: US FDA Approves Nerlynx And Vosevi, Turns Down Evenity; Macrilen Returns
News and highlights about novel agents from our FDA Performance Tracker.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Osteoporosis treatment romosozumab-aqqg indicated for postmenopausal women at high risk for fracture; advisory committee appears to have help persuade FDA that a black box would be sufficient to manage cardiovascular risk rather than a narrower indication.
The agency's Dec. 21 approval of Giapreza became novel drug No. 46 of 2017, topping the 2015 mark of 45.