Keeping Track: FDA Approves Epclusa, Designates Four Breakthrough Therapies, Files Burst Of Applications
The latest drug development news and highlights from our FDA Performance Tracker.
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Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.
The latest drug development news and highlights from our US FDA Performance Tracker.
Lipocine resubmits Tlando NDA with new study data supporting twice-daily fixed dosing regimen for the oral testosterone replacement candidate; FDA action expected by Feb. 8.