2023 New Drug Approvals: Part 3

In part 3 of this slideshow series, take a look back at the novel drugs and therapeutics approved by the FDA in 2023,¹ including treatments for large B-cell lymphoma, respiratory syncytial virus (RSV), and acute myeloid leukemia (AML).

References

1. Novel drug approvals for 2023. FDA. Reviewed November 28, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023

2. FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas. FDA. June 16, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell

3. FDA approves Pfizer’s Litfulo (ritlecitinib) for adults and adolescents with severe alopecia areata. News release. Pfizer. June 23, 2023. Accessed November 28, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and

4. UCB announces US FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis. News release. UCB. June 28, 2023. Accessed November 28, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-US-FDA-approval-of-RYSTIGGOR-rozanolixizumab-noli-for-the-treatment-of-adults-with-generalized-myasthenia-gravis

5. FDA approves Pfizer’s Ngenla, a long-acting once-weekly treatment for pediatric growth hormone deficiency. June 28, 2023. Accessed November 28, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-ngenlatm-long-acting-once-weekly

6. FDA approves new drug to prevent RSV in babies and toddlers. News release. FDA. July 17, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

7. FDA approves quizartinib for newly diagnosed acute myeloid leukemia. FDA. July 20, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia

8. FDA approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. News release. Tarsus Pharmaceuticals. July 25, 2023. Accessed November 28, 2023. https://ir.tarsusrx.com/news-releases/news-release-details/fda-approves-xdemvytm-lotilaner-ophthalmic-solution-025