2023 New Drug Approvals: Part 5

In the final part of this slideshow series, take a look back at the novel drugs and therapeutics approved by the FDA in 2023,¹ including treatments for ulcerative colitis, neutropenia, desmoid tumors, and more.

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. US FDA approves Pfizer’s Velsipity for adults with moderately to severely active ulcerative colitis (UC). News release. Pfizer. October 13, 2023. Accessed November 28, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-velsipitytm-adults-moderately

3. UCB announces US FDA approval of Zilbrysq (zilucoplan) for the treatment of adults with generalized myasthenia gravis. News release. UCB. October 17, 2023. Accessed November 28, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-US-FDA-approval-of-ZILBRYSQR-zilucoplan-for-the-treatment-of-adults-with-generalized-myasthenia-gravis

4. Bimzelx approved by the US FDA for the treatment of adults with moderate to severe plaque psoriasis. News release. UCB. October 18, 2023. Accessed November 28, 2023. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis

5. Santhera receives US FDA approval ofo Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy. News release. Santhera Pharmaceuticals. October 27, 2023. Accessed November 28, 2023.https://www.santhera.com/assets/files/press-releases/2023-10-27_FDA-approval_e_final.pdf

6. FDA approves Lilly’s Omvoh (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis. News release. Eli Lilly. October 26, 2023. Accessed November 28, 2023. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class

7. FDA approves toripalimab-tpzi for nasopharyngeal carcinoma. FDA. October 30, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma

8. FDA approves fruquintinib in refractory metastatic colorectal cancer. FDA. November 8, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-refractory-metastatic-colorectal-cancer

9. FDA approves new drug under special pathway for patients receiving hemodialysis. FDA. November 15, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-under-special-pathway-patients-receiving-hemodialysis

10. FDA approves repotrectinib for ROS1-positive non-small cell lung cancer. FDA. November 16, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-ros1-positive-non-small-cell-lung-cancer

11. Evive Biotech and Acrotech Biopharma announce FDA approval of Ryzneuta (efbemalenograstim alfa injection) for chemotherapy-induced neutropenia (CIN). News release. Acrotech Biopharma. November 22, 2023. Accessed November 28, 2023. https://acrotechbiopharma.com/wp-content/uploads/2023/11/Evive-and-Acrotech-Announce-FDA-Approval-of-Ryzneuta.pdf

12. Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer. News release. AstraZeneca. November 17, 2023. Accessed November 28, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/truqap-approved-in-us-for-hr-plus-breast-cancer.html

13. FDA approves capivasertib with fulvestrant for breast cancer. FDA. November 16, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer

14. FDA approves first therapy for rare type of noncancerous tumors. News release. FDA. November 27, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-type-non-cancerous-tumors

15. SpringWorks Therapeutics announces FDA approval of Ogsiveo (nirogacestat) as the first and only treatment for adults with desmoid tumors. News release. SpringWorks Therapeutics. November 27, 2023. Accessed November 28, 2023. https://ir.springworkstx.com/news-releases/news-release-details/springworks-therapeutics-announces-fda-approval-ogsiveotm