First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year
Executive Summary
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.
You may also be interested in...
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.
It's Time For Novartis To Put Its Leqvio Launch Strategy To The Test
Novartis Pharmaceuticals US head Victor Bulto talks to Scrip about the launch of Leqvio; the cholesterol-lowering medicine now approved by the US FDA.
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