2023 New Drug Approvals: Part 2

In part 2 of this slideshow series, take a look back at the novel drugs and therapeutics approved by the FDA in 2023,¹ including treatments for amyotrophic lateral sclerosis (ALS), vasomotor symptoms of menopause, and migraine.

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. Pfizer’s Zavzpret (zavegepant) migraine nasal spray receives FDA approval. News release. Pfizer. March 10, 2023. Accessed November 28, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-zavzprettm-zavegepant-migraine-nasal-spray

3. FDA approves first treatment for Rett Syndrome. FDA. March 13, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-rett-syndrome

4. Incyte announces FDA approval of Zynyz (retifanlimab-dlwr) for the treatment of metastatic or recurrent locally advanced merkel cell carcinoma (MCC). News release. Incyte. March 22, 2023. Accessed November 28, 2023. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-zynyztm-retifanlimab-dlwr

5. Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. News release. Cidara Therapeutics. March 22, 2023. Accessed November 28, 2023. https://www.cidara.com/news/cidara-therapeutics-and-melinta-therapeutics-announce-fda-approval-of-rezzayo-rezafungin-for-injection-for-the-treatment-of-candidemia-and-invasive-candidiasis/

6. FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome. FDA. March 24, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-activated-phosphoinositide-3-kinase-delta-syndrome

7. FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene. FDA. April 25, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-amyotrophic-lateral-sclerosis-associated-mutation-sod1-gene

8. Chiesi Global Rare Diseases and Protalix BioTherapeutics announce FDA approval of Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry Disease. News release. Chiesi Global Rare Diseases. May 10, 2023. Accessed November 28, 2023. https://www.prnewswire.com/news-releases/chiesi-global-rare-diseases-and-protalix-biotherapeutics-announce-fda-approval-of-elfabrio-pegunigalsidase-alfa-iwxj-for-the-treatment-of-fabry-disease-301820680.html

9. FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. News release. FDA. May 12, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause

10. Bauch + Lomb and Novaliq announce FDA approval of Miebo (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease. News release. Bausch + Lomb. May 18, 2023. Accessed November 28, 2023. https://ir.bausch.com/press-releases/bausch-lomb-and-novaliq-announce-fda-approval-miebotm-perfluorohexyloctane

11. FDA D.I.S.C.O. burst edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed ro refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. FDA. June 21, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-epkinly-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b

12. FDA approves new treatment for pneumonia caused by certain difficult-to-treat bacteria. News release. FDA. May 23, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria

13. FDA approves first oral antiviral for treatment of COVID-19 in adults. News release. FDA. May 25, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults

14. US FDA approves Blue Earth Diagnostics’ Posluma (Flotufolastat F 18) injection, first radiohybrid PSMA-targeted PET imaging agent for prostate cancer. News release. Blue Earth Diagnostics. May 30, 2023. Accessed November 28, 2023. https://www.businesswire.com/news/home/20230530005180/en/U.S.-FDA-Approves-Blue-Earth-Diagnostics%E2%80%99-POSLUMA%C2%AE-Flotufolastat-F-18-Injection-First-Radiohybrid-PSMA-targeted-PET-Imaging-Agent-for-Prostate-Cancer

15. Lexicon announces FDA approval of Inpefa (sotagliflozin) for treatment of heart failure. News release. Lexicon Pharmaceuticals. May 26, 2023. Accessed November 28, 2023. https://www.globenewswire.com/en/news-release/2023/05/26/2677371/0/en/Lexicon-Announces-FDA-Approval-of-INPEFA-sotagliflozin-for-Treatment-of-Heart-Failure.html