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US FDA Performance Tracker Approvals Drug Review

Keeping Track: Novel Orphan Drugs Amondys 45, Nulibry Clear US FDA; First-Line NSCLC Claim For Libtayo

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa

Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

Boehringer & BridgeBio Seek EU Fast-Track Status; Enfortumab Vedotin Reverts To Standard Review

Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.

Keeping Track: Ticovac Is Latest Win For Pfizer’s Vaccine Business; Doors Open For BMS And GSK PD-1 Inhibitors

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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