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.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.