Latest From Bridget Silverman
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.
Our infographic shows the various routes that the 60 novel agents took to approval, from Real-Time Oncology Review to Qualified Infectious Disease Product designation.
Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.
Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.
Keeping Track: Immunology Drives US FDA Action, With Approvals For AZ/Amgen’s Tezspire, Argenx’s Vyvgart, And New JAK Uses
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.