Latest From Bridget Silverman
A team led by Dalhousie University researchers examined 174 novel approvals from 2011-2015 and found 155 instances of disagreement, affecting 42 drugs.
Keeping Track: Veklury NDA Arrives At US FDA; Olinvyk Sees Approval; MAb Filings By Regneron, Y-mAbs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The latest US FDA approvals and actions from the Pink Sheet’s US FDA Performance Tracker.
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker
Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.