Keeping Track: FDA Clears Big Batch Of Products; 'Breakthrough' For Bristol HIV Drug
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Biotech firm hopes its once-shelved antibiotic will provide a therapeutic option for renally impaired patients with serious skin infections. With only one previous DHFR inhibitor ever approved, Motif also anticipates that iclaprim will offer an option for multidrug-resistant infections.
Keeping Track: Opana ER Abuse Deterrence Claim Withdrawn; Third Neulasta Biosimilar Submitted; Keytruda Cleared In Head And Neck Cancer
The latest drug development news and highlights from our FDA Performance Tracker.
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).