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FDA Performance Tracker

Set Alert for FDA Performance Tracker

Keeping Track: Amarin And Nektar Signal Delays, DBV Returns, And Provention Notches A BTD

The latest drug development news and highlights from our US FDA Performance Tracker.

Drug Review Complete Response Letters Regulation

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

The latest oncology development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Cancer

Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News

The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings

Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.

US FDA Performance Tracker Drug Review

Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar

The latest news on US FDA drug approvals.

US FDA Performance Tracker Approvals

Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa

The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Keeping Track Of Review Designations: BTDs For X4, F2G, And BMS; Another QIDP For Allergan

The latest news about products accepted into US FDA expedited review programs.

US FDA Performance Tracker Research & Development

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.

US FDA Performance Tracker Approvals

Keeping Track: Biosimilars, Novel Approvals, And Ebola

The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.

US FDA Performance Tracker Approvals
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