Latest From Bridget Silverman
The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).
News and highlights from the Pink Sheet’s US FDA Performance Tracker
Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.