Bridget Silverman
Senior Editor
Latest From Bridget Silverman
US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021
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).
Keeping Track: Breakthrough Designations Fuel Expansion Of Genomically-Defined NSCLC Therapy
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
First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.
US FDA’s 2021 Novel Approvals: A Closer Look
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.