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2021 Orphan Drugs: PDUFA Dates and FDA Approvals

PDUFA Date Orphan Drug Company Status N/A Tepotinib Merck APPROVED 2.3.2021 2.11.2021 Evinacumab Regeneron APPROVED 2.11.2021 2.15.2021 Umbralisib TG Therapeutics APPROVED 2.5.2021

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