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

More from Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.