US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count
Executive Summary
The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.
You may also be interested in...
As FDA Decision Nears, Novartis Highlights New Analysis Of Blockbuster Hopeful Inclisiran
Novartis has pooled cholesterol control and safety data, but will have to wait longer for cardiovascular outcomes readout.
Roxadustat Stacks Up To Darbepoietin In Non-Dialysis Anemia
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.
Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever
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.