US FDA Picks Up The Pace Of Complete Response Letters Over June And July
Executive Summary
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
You may also be interested in...
Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Heron Overcomes Two CRLs To Win Zynrelef Approval In Post-Op Pain
The combination of bupivacaine and meloxicam will be priced at a discount to Exparel, with Heron predicting rapid uptake. Label limited to three surgery types, but analysts expect off-label use.
US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics
FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.