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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: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta

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

US FDA Performance Tracker Approvals

Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals

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

US FDA Performance Tracker Approvals

Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements

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

US FDA Performance Tracker Approvals

Keeping Track: Intercept Submits OCA For NASH; Zogenix’ Fintepla Returns; US FDA Approves Bavarian Nordic Vaccine

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

US FDA Performance Tracker Drug Review

Keeping Track: A Duo Of RTOR Approvals, Thumbs Up For First Oral GLP-1 Treatment, And First Ebola Vaccine Nears US Market

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

US FDA Performance Tracker Approvals

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD

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

US FDA Performance Tracker Approvals

Novel CDER Approvals

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.

US FDA Performance Tracker Approvals

CBER Novel Approvals

Biologics cleared by the Center for Biologics Evaluation and Research, including vaccines, cellular products, antitoxins and immunoglobulins. Updated regularly with new approvals.

US FDA Performance Tracker Approvals
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