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Keeping Track: Opana ER Abuse Deterrence Claim Withdrawn; Third Neulasta Biosimilar Submitted; Keytruda Cleared In Head And Neck Cancer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.
PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year
In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.