Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
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AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.