US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count
The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.
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Novartis has pooled cholesterol control and safety data, but will have to wait longer for cardiovascular outcomes readout.
Astellas’s oral HIF-PH inhibitor shows non-inferiority to one established ESA in head-to-head trial and while there were cardiovascular benefits, the picture is complex.
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.