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Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen
The latest drug development news and highlights from our US FDA Performance Tracker.
A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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.
New molecular entities and therapeutic biologics cleared by the US FDA's Center for Drug Evaluation and Research. Updated regularly with new approvals.
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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