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.
Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.