FDA Performance Tracker
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Keeping Track: Bristol Tests US FDA’s TMB Tolerance, Celltrion Resubmits Herceptin Biosimilar, Nocdurna Approved At Last
The latest drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi
New molecular entities and therapeutic biologics cleared by the US FDA's Center for Drug Evaluation and Research. Our FDA Performance Tracker chart is updated regularly with new approvals.
Biologics cleared by the Center for Biologics Evaluation and Research, including vaccines, cellular products, antitoxins and immunoglobulins. Updated regularly with new approvals.
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.
Drug review recommendations from FDA advisory panels, including regulatory actions. Updated weekly.
Details of action letters issued by US FDA, regularly updated with new announcements.
Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.
Estimated FDA review deadlines for pending applications. Updated weekly.
Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.
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