2023 New Drug Approvals: Part 4

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 postpartum depression, relapsed or refractory multiple myeloma, and major depressive disorder.

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 approves first oral treatment for postpartum depression. News release. FDA. August 4, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression

3. Iveric Bio receives US FDA approval for izervay (avacincaptad pegol intravitreal solution), a new treatment for geographic atrophy. News release. Astellas Pharma. August 5, 2023. Accessed November 28, 2023. https://www.astellas.com/en/news/28281

4. US FDA approves Talvey (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. News release. Johnson & Johnson. August 10, 2023. Accessed November 28, 2023. https://www.jnj.com/u-s-fda-approves-talvey-talquetamab-tgvs-a-first-in-class-bispecific-therapy-for-the-treatment-of-patients-with-heavily-pretreated-multiple-myeloma

5. FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma. FDA. August 14, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma

6. US FDA approves Ipseon’s Sohonos (palovarotene) capsules, the first and only treatment for people with fibrodysplasia ossificans progressive. August 16, 2023. Accessed November 28, 2023. https://www.ipsen.com/us/press-releases/us-fda-approves-ipsens-sohonostm-palovarotene-capsules-the-first-and-only-treatment-for-people-with-fibrodysplasia-ossificans-progressiva/

7. Veopoz (pozelimab-bbfg) receives FDA approval as the first treatment for children and adults with Chaple disease. News release. Regeneron. August 18, 2023. Accessed November 28, 2023. https://investor.regeneron.com/news-releases/news-release-details/veopoztm-pozelimab-bbfg-receives-fda-approval-first-treatment

8. BioLineRx announces FDA approval of Aphexda (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. News release. BioLineRx. September 11, 2023. Accessed November 28, 2023. https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-announces-fda-approval-aphexdatm-motixafortide

9. Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia. News release. GSK. September 15, 2023. Accessed November 28, 2023. https://www.gsk.com/en-gb/media/press-releases/ojjaara-momelotinib-approved-in-the-us-as-the-first-and-only-treatment-indicated-for-myelofibrosis-patients-with-anaemia/

10. Fabre-Kramer Pharmaceuticals announces FDA approval of Exxua, the first and only oral selective 5HT1a receptor agonist for the treatment of major depressive disorder in adults. News release. Fabre-Kramer Pharmaceuticals. September 28, 2023. Accessed November 28, 2023. https://www.prnewswire.com/news-releases/fabre-kramer-pharmaceuticals-announces-fda-approval-of-exxua-the-first-and-only-oral-selective-5ht1a-receptor-agonist-for-the-treatment-of-major-depressive-disorder-in-adults-301941467.html

11. Amicus Therapeutics announces FDA approval and launch of new treatment for Pompe disease. News release. Amicus Therapeutics. September 28, 2023. Accessed November 28, 2023. https://ir.amicusrx.com/news-releases/news-release-details/amicus-therapeutics-announces-fda-approval-and-launch-new

12. FDA approves Rivfloza for children ≥9 years old and adults living with primary hyperoxaluria type 1 (PH1), a rare genetic condition. News release. Novo Nordisk. October 2, 2023. Accessed November 28, 2023. https://www.prnewswire.com/news-releases/fda-approves-rivfloza-for-children-9-years-old-and-adults-living-with-primary-hyperoxaluria-type-1-ph1-a-rare-genetic-condition-301944564.html