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Upcoming FDA Actions, January Through March 2024

December 2023 Vol 16, Payers' Guide to FDA Updates - FDA Pipeline
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January-March 2024 FDA Pipeline

References

  1. Standard FDA calendar. FDA Tracker. Accessed December 6, 2023. https://www.fdatracker.com/fda-calendar/
  2. Checkpoint Therapeutics, Inc. Checkpoint Therapeutics announces FDA filing acceptance of biologics license application for cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. U.S. Securities and Exchange Commission. Accessed November 1, 2023. https://www.sec.gov/Archives/edgar/data/1651407/000110465923027655/tm238273d1_ex99-1.htm
  3. Novan Inc. Berdazimer gel 10.3% (SB206). Novan. Accessed November 1, 2023. https://novan.com/berdazimer-gel-10-3-sb206/
  4. Novan Inc. FDA accepts Novan’s NDA for berdazimer gel, 10.3% for the treatment of Molluscum contagiosum with a PDUFA goal date of January 5, 2024. GlobeNewswire News Room. Published March 7, 2023. Accessed November 1, 2023. https://www.globenewswire.com/news-release/2023/03/07/2622009/0/en/FDA-Accepts-Novan-s-NDA-for-Berdazimer-Gel-10-3-for-the-Treatment-of-Molluscum-Contagiosum-with-a-PDUFA-Goal-Date-of-January-5-2024.html
  5. FDA accepts for priority review Merck’s supplemental new drug application for WELIREG (belzutifan) in certain previously treated patients with advanced renal cell carcinoma (RCC). Business Wire. Published September 19, 2023. Accessed December 6, 2023. https://www.businesswire.com/news/home/20230919584956/en/FDA-Accepts-for-Priority-Review-Merck%E2%80%99s-Supplemental-New-Drug-Application-for-WELIREG%C2%AE-belzutifan-in-Certain-Previously-Treated-Patients-With-Advanced-Renal-Cell-Carcinoma-RCC
  6. Ailani J, Albrecht D, Cowan R. Efficacy of STS101 DHE nasal powder for the acute treatment of difficult to treat migraines: results from the phase 3 double-blind, randomized, placebo-controlled SUMMIT study. Poster presented at: American Headache Society (AHS) Annual Meeting; June 15, 2023; Austin, TX. Accessed December 6, 2023. https://www.satsumarx.com/wp-content/uploads/2023/05/Satsuma_AHS_2023_P213_Final_15May2023.pdf
  7. FDA grants priority review to Merck’s application for KEYTRUDA (pembrolizumab) plus concurrent chemoradiotherapy as treatment for patients with newly diagnosed high-risk locally advanced cervical cancer. Business Wire. Published September 20, 2023. Accessed November 15, 2023. https://www.businesswire.com/news/home/20230920107710/en/FDA-Grants-Priority-Review-to-Merck%E2%80%99s-Application-for-KEYTRUDA%C2%AE-pembrolizumab-Plus-Concurrent-Chemoradiotherapy-as-Treatment-for-Patients-With-Newly-Diagnosed-High-Risk-Locally-Advanced-Cervical-Cancer
  8. Theratechnologies. Theratechnologies receives January 2024 PDUFA goal date for tesamorelin F8 formulation sBLA. GlobeNewswire News Room. Published October 4, 2023. Accessed November 15, 2023. https://www.globenewswire.com/news-release/2023/10/04/2754473/0/en/Theratechnologies-Receives-January-2024-PDUFA-Goal-Date-for-Tesamorelin-F8-Formulation-sBLA.html
  9. Form 10-Q (Heron Therapeutics, Inc.). U.S. Securities and Exchange Commission. Published August 14, 2023. Accessed November 15, 2023. https://www.sec.gov/Archives/edgar/data/818033/000095017023042431/hrtx-20230630.htm
  10. Zare P, Heller D. Treprostinil. In: StatPearls. StatPearls Publishing; 2023. Accessed November 29, 2023. http://www.ncbi.nlm.nih.gov/books/NBK545152/
  11. Form 8-K (Liquidia Corporation). U.S. Securities and Exchange Commission. Published September 25, 2023. Accessed November 29, 2023. https://www.sec.gov/Archives/edgar/data/1819576/000110465923103552/tm2326854d1_8k.htm
  12. Regeneron Pharmaceuticals Inc. Dupixent (dupilumab) sBLA for treatment of eosinophilic esophagitis (EoE) in children aged 1 to 11 accepted for FDA priority review. GlobeNewswire News Room. Published September 26, 2023. Accessed November 29, 2023. https://www.globenewswire.com/news-release/2023/09/26/2749147/0/en/Dupixent-dupilumab-sBLA-for-Treatment-of-Eosinophilic-Esophagitis-EoE-in-Children-Aged-1-to-11-Accepted-for-FDA-Priority-Review.html
  13. FDA accepts application for Merck’s KEYTRUDA (pembrolizumab) plus chemotherapy as treatment for advanced or unresectable biliary tract cancer. Business Wire. Published June 8, 2023. Accessed November 29, 2023. https://www.businesswire.com/news/home/20230608005213/en/FDA-Accepts-Application-for-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Plus-Chemotherapy-as-Treatment-for-Advanced-or-Unresectable-Biliary-Tract-Cancer
  14. Iovance Biotherapeutics Inc. U.S. Food and Drug Administration updates Prescription Drug User Fee Act (PDUFA) action date for lifileucel for the treatment of advanced melanoma. GlobeNewswire News Room. Published September 14, 2023. Accessed November 29, 2023. https://www.globenewswire.com/news-release/2023/09/14/2743715/0/en/U-S-Food-and-Drug-Administration-Updates-Prescription-Drug-User-Fee-Act-PDUFA-Action-Date-for-Lifileucel-for-the-Treatment-of-Advanced-Melanoma.html
  15. Minerva Neurosciences Inc. Minerva Neurosciences announces update on its New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in schizophrenia. GlobeNewswire News Room. Published May 10, 2023. Accessed December 4, 2023. https://www.globenewswire.com/news-release/2023/05/10/2665474/32445/en/Minerva-Neurosciences-Announces-Update-on-its-New-Drug-Application-NDA-for-Roluperidone-for-the-Treatment-of-Negative-Symptoms-in-Schizophrenia.html
  16. EudraCT number 2014-004878-42 - clinical trial results. EU Clinical Trials Register. Published September 27, 2018. Accessed December 4, 2023. https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004878-42/results
  17. Eyenovia. Eyenovia acquires U.S. commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa Pharmaceuticals. U.S. Securities and Exchange Commission. Published August 16, 2023. Accessed December 4, 2023. https://www.sec.gov/Archives/edgar/data/1682639/000110465923092219/tm2323901d1_ex99-1.htm
  18. Viatris Inc. Viatris and Mapi Pharma announce FDA acceptance of New Drug Application filing for GA depot for the treatment of relapsing forms of multiple sclerosis. Cision PR Newswire. Published August 7, 2023. Accessed December 4, 2023. https://www.prnewswire.com/news-releases/viatris-and-mapi-pharma-announce-fda-acceptance-of-new-drug-application-filing-for-ga-depot-for-the-treatment-of-relapsing-forms-of-multiple-sclerosis-301894145.html
  19. Form 8-K (Mirum Pharmaceuticals, Inc.). U.S. Securities and Exchange Commission. Published October 17, 2023. Accessed December 4, 2023. https://www.sec.gov/Archives/edgar/data/1759425/000119312523257711/d548350d8k.htm
  20. LIVMARLITM (Maralixibat) Oral Solution. Mirum Pharmaceuticals; 2021. Accessed December 4, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214662s001lbl.pdf
  21. BREYANZI (Lisocabtagene Maraleucel) Suspension for Intravenous Infusion prescribing information. Juno Therapeutics, Inc; 2022. Accessed December 4, 2023. https://packageinserts.bms.com/pi/pi_breyanzi.pdf
  22. U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Business Wire. Published November 9, 2023. Accessed December 4, 2023. https://www.businesswire.com/news/home/20231109738749/en/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibb%E2%80%99s-Application-for-Breyanzi-lisocabtagene-maraleucel-for-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL
  23. Madrigal Pharmaceuticals. Madrigal Pharmaceuticals announces NDA acceptance and priority review of the New Drug Application for resmetirom for the treatment of NASH with liver fibrosis. U.S. Securities and Exchange Commission. Published September 13, 2023. Accessed December 6, 2023. https://www.sec.gov/Archives/edgar/data/1157601/000119312523234385/d475156dex991.htm
  24. Orchard Therapeutics. Orchard Therapeutics announces acceptance of Biologics License Application for OTL-200 in MLD and receives priority review. U.S. Securities and Exchange Commission. Published September 18, 2023. Accessed December 6, 2023. https://www.sec.gov/Archives/edgar/data/1748907/000095017023048466/ortx-ex99_1.htm
  25. Libmeldy (Atidarsagene Autotemcel) [Summary of Product Characteristics (SmPC)]. Orchard Therapeutics (Netherlands) B.V.; 2020. Accessed December 6, 2023. https://www.ema.europa.eu/en/documents/product-information/libmeldy-epar-product-information_en.pdf
  26. Merck receives priority review from FDA for new Biologics License Application for sotatercept, an activin signaling inhibitor to treat adults with pulmonary arterial hypertension (PAH). Business Wire. Published September 28, 2023. Accessed December 6, 2023. https://www.businesswire.com/news/home/20230928840253/en/Merck-Receives-Priority-Review-from-FDA-for-New-Biologics-License-Application-for-Sotatercept-an-Activin-Signaling-Inhibitor-to-Treat-Adults-with-Pulmonary-Arterial-Hypertension-PAH
  27. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.
  28. Akebia Therapeutics. Akebia receives FDA acceptance of resubmission to NDA of vadadustat for the treatment of anemia due to chronic kidney disease. Cision PR Newswire. Accessed December 6, 2023. https://www.prnewswire.com/news-releases/akebia-receives-fda-acceptance-of-resubmission-to-nda-of-vadadustat-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-301967287.html
  29. NEXLETOL (Bempedoic Acid) Tablets, for Oral Use [Prescribing Information]. Esperion Therapeutics, Inc; 2023. Accessed December 6, 2023. https://pi.esperion.com/nexletol/nexletol-pi.pdf
  30. Esperion Therapeutics Inc. Esperion reports third quarter 2023 financial results. GlobeNewswire News Room. Published November 7, 2023. Accessed December 6, 2023. https://www.globenewswire.com/news-release/2023/11/07/2774813/0/en/Esperion-Reports-Third-Quarter-2023-Financial-Results.html
  31. NEXLIZET (Bempedoic Acid and Ezetimibe) Tablets [Prescribing Information]. Esperion Therapeutics, Inc; 2023. Accessed December 6, 2023. https://pi.esperion.com/nexlizet/nexlizet-pi.pdf
  32. Rocket Pharmaceuticals announces FDA acceptance of Biologics License Application with priority review for RP-L201 (marnetegragene autotemcel) for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I). Business Wire. Published October 2, 2023. Accessed December 6, 2023. https://www.businesswire.com/news/home/20231002809583/en/Rocket-Pharmaceuticals-Announces-FDA-Acceptance-of-Biologics-License-Application-with-Priority-Review-for-RP-L201-marnetegragene-autotemcel-for-the-Treatment-of-Severe-Leukocyte-Adhesion-Deficiency-I-LAD-I
  33. Regeneron Pharmaceuticals Inc. Odronextamab BLA for treatment of relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) accepted for FDA priority review. GlobeNewswire News Room. Published September 29, 2023. Accessed December 6, 2023. https://www.globenewswire.com/news-release/2023/09/29/2751977/0/en/Odronextamab-BLA-for-Treatment-of-Relapsed-Refractory-Follicular-Lymphoma-FL-and-Diffuse-Large-B-cell-Lymphoma-DLBCL-Accepted-for-FDA-Priority-Review.html
Last modified: January 29, 2024