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. 2023 May 12;11(5):1434. doi: 10.3390/biomedicines11051434

Table 2.

Orphan Drug Status granted by the FDA from 2015 to 2022.

Year Biologics Approved Orphan Drug Status Granted for New Biologics References
2015 13 7 (53%) [10]
2016 7 2 (28%) [9]
2017 13 5 (38%) [8]
2018 17 13 (76%) [7]
2019 12 9 (75%) [6]
2020 15 10 (66%) [5]
2021 14 7 (50%) [4]
2022 15 7 (46%) [3]