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Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

 
• By Bridget Silverman

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.

No matter how tumultuous the times, the novel drugs and biologics approved by the US FDA in 2020 show the continuation, and even acceleration of previous themes as the novel drug and biologic class became more weighted toward regulatory incentives and expedited review pathways.

The FDA’s flagship expedited review program, the breakthrough therapy designation, nurtured 22 novel agents to 2020 approval at the Center for Drug Evaluation and Research, a number notable in both absolute and relative terms

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