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Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel

Executive Summary

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

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Earlier-Stage Approvals For Tecentriq, Keytruda, Verzenio Underscore Broader Oncology Trends

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

Finance Watch: Exo Raises $78m To Advance Exosite-Targeting Small Molecules

Also, Atlas Venture and Advent France Biotechnology raise new venture capital funds, Corium secures $235m in debt to commercialize ADHD drug and CBMG leads recent VC financings with $120m series A round.

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

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