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Rhythm Pharmaceuticals, Inc.

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Bristol Myers Squibb's lisocabtagene maraleucel, UCB's bimekizumab and Rhythm Pharmaceuticals' setmelanotide are among the six latest additions to the list of products under review at the European Medicines Agency.

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EU Accelerated Assessment Tracker

Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

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Latest EU Filings Include A First For BeiGene

Potential treatments from BeiGene, AstraZeneca, Bayer and Cancer Prevention Pharmaceuticals are under review at the European Medicines Agency.

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Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach

With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.

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  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
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    • Rhythm Metabolic, Inc.
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