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FDA Performance Tracker

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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: Ayvakit Approval, Keytruda Supplement, NME Submissions

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

US FDA Performance Tracker Approvals

Keeping Track: Year-End Submissions Rush Brings Seven Novel Agents To US FDA

Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.

Drug Review Review Pathway

Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019

The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Keeping Track: Vascepa Adds CV Risk Reduction Claim And Submissions Pour Into FDA

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

US FDA Performance Tracker Approvals

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
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