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The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively. Going into the third year of the pandemic, we know that the virus still impacts industry operations.
In parallel, FOCR developed a whitepaper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.
Today there are 15 FDA-approved ADCs for oncology. Numerous whitepapers, scientific publications, presentations, and industry news articles focus on ADCs. The Right Formulation All FDA-approved ADCs are administered through intravenous injections, and all are approved for cancer indications.
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