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.
Vaxneuvance, Prevnar 20 Earn CDC Cmte Nod For Age- And Risk-Based Use; Broader Shingrix Use Supported
ACIP votes unanimously to recommend Merck and Pfizer’s pneumococcal vaccines in elderly and immunocompromised adults; GSK’s herpes zoster vaccine also gets unanimous nod for immunocompromised adults.