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Jazz Pharmaceuticals PLC

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EU Accelerated Assessment Tracker

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

Europe Drug Review

GSK: Please, EMA, Can We Have Some More?

Hot on the heels of winning EU fast-track review status for belantamab mafodotin, GlaxoSmithKline has asked the European Medicines Agency to grant accelerated assessment to another of its planned marketing applications.

Europe Approvals

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Approvals Drug Review

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

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

US FDA Performance Tracker Approvals
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