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US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

 
• By Bridget Silverman

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Pipeline
Unlike this pipeline, the US FDA's NME class of 2020 looks quite deep.

A diverse field of candidates populates the US Food and Drug Administration’s user fee calendar for 2020, outside of the clear dominance of cancer and neuroscience therapies and familiar big pharma sponsors.

The already large list of novel agents under FDA provides the space for a few sectors with many candidates and...

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Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
• By Tim Casey

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Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
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• By Vibha Sharma

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