1. | Leqembi | lecanemab-irmb | 1/6/2023 | To treat Alzheimer’s disease Press Release |
2. | Brenzavvy | bexagliflozin | 1/20/2023 | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise Drug Trials Snapshot |
3. | Jaypirca | pirtobrutinib | 1/27/2023 | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor Drug Trials Snapshot |
4. | Orserdu | elacestrant | 1/27/2023 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy Drug Trials Snapshot |
5. | Jesduvroq | daprodustat | 2/1/2023 | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months Press Release Drug Trials Snapshot |
6. | Lamzede | velmanase alfa-tycv | 2/16/2023 | To treat non-central nervous system manifestations of alpha-mannosidosis |
7. | Filspari | sparsentan | 2/17/2023 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
8. | Skyclarys | omaveloxolone | 2/28/2023 | To treat Friedrich’s ataxia Drug Trials Snapshots |
9. | Zavzpret | zavegepant | 3/9/2023 | To treat migraine |
10. | Daybue | trofinetide | 3/10/2023 | To treat Rett syndrome |
11. | Zynyz | retifanlimab-dlwr | 3/22/2023 | To treat metastatic or recurrent locally advanced Merkel cell carcinoma |
12. | Rezzayo | rezafungin | 3/22/2023 | To treat candidemia and invasive candidiasis |
13. | Joenja | leniolisib | 3/24/2023 | To treat activated phosphoinositide 3-kinase delta syndrome |
14. | Qalsody | tofersen | 4/25/2023 | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation |
15. | Elfabrio | pegunigalsidase alfa-iwxj | 5/9/2023 | To treat confirmed Fabry disease |
16. | Veozah | fezolinetant | 5/12/2023 | To treat moderate to severe hot flashes caused by menopause Press Release |
17. | Miebo | perfluorhexyloctane | 5/18/2023 | To treat signs and symptoms of dry eye disease |
18. | Epkinly | epcoritamab-bysp | 5/19/2023 | To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy |
19. | Xacduro | sulbactam, durlobactam | 5/23/2023 | To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex Press Release |
20. | Paxlovid | nirmatrelvir, ritonavir | 5/25/2023 | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 Press Release Drug Trials Snapshot |
21. | Posluma | flotufolastat F 18 | 5/25/2023 | To use with positron emission tomography imaging in certain patients with prostate cancer Drug Trials Snapshot |
22. | Inpefa | sotagliflozin | 5/26/2023 | To treat heart failure |
23. | Columvi | glofitamab-gxbm | 6/15/2023 | To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy Drug Trials Snapshot |
24. | Litfulo | ritlecitinib | 6/23/2023 | To treat severely patchy hair loss Drug Trials Snapshot |
25. | Rystiggo | rozanolixizumab-noli | 6/26/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive |
26. | Ngenla | somatrogon-ghla | 6/27/2023 | To treat growth failure due to inadequate secretion of endogenous growth hormone Drug Trials Snapshot |
27. | Beyfortus | nirsevimab-alip | 7/17/2023 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease Press Release Drug Trials Snapshot |
28. | Vanflyta | quizartinib | 7/20/2023 | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria Drug Trials Snapshot |
29. | Xdemvy | lotilaner | 7/25/2023 | To treat Demodex blepharitis |
30. | Zurzuvae | zuranolone | 8/4/2023 | To treat postpartum depression Press Release |
31. | Izervay | avacincaptad pegol | 8/4/2023 | To treat geographic atrophy secondary to age-related macular degeneration |
32. | Talvey | talquetamab-tgvs | 8/9/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies |
33. | Elrexfio | elranatamab-bcmm | 8/14/2023 | To treatadults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy |
34. | Sohonos | palovarotene | 8/16/2023 | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva |
35. | Veopoz | pozelimab-bbfg | 8/18/2023 | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease |
36. | Aphexda | motixafortide | 9/8/2023 | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma Drug Trials Snapshot |
37. | Ojjaara | momelotinib | 9/15/2023 | To treatintermediate or high-risk myelofibrosis in adults with anemia |
38. | Exxua | gepirone | 9/22/2023 | To treat major depressive disorder |
39. | Pombiliti | cipaglucosidase alfa-atga | 9/28/2023 | To treat late-onset Pompe disease Drug Trials Snapshot |
40. | Rivfloza | nedosiran | 9/29/2023 | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function |
41. | Velsipity | etrasimod | 10/12/2023 | To treat moderately to severely active ulcerative colitis in adults |
42. | Zilbrysq | zilucoplan | 10/17/2023 | Totreat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive |
43. | Bimzelx | bimekizumab | 10/17/2023 | To treat moderate to severeplaque psoriasisin adults who are candidates for systemic therapy or phototherapy Drug Trials Snapshot |
44. | Agamree | vamorolone | 10/26/2023 | To treat duch*enne muscular dystrophy Drug Trials Snapshot |
45. | Omvoh | mirikizumab-mrkz | 10/26/2023 | To treat ulcerative colitis |
46. | Loqtorzi | toripalimab-tpzi | 10/27/2023 | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies |
47. | Fruzaqla | fruquintinib | 11/8/2023 | To treat refractory, metastatic colorectal cancer |
48. | Defencath | taurolidine, heparin | 11/15/2023 | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter |
49. | Augtyro | repotrectinib | 11/15/2023 | To treat ROS1-positive non-small cell lung cancer |
50. | Ryzneuta | efbemalenograstim alfa-vuxw | 11/16/2023 | To treat neutropenia Drug Trials Snapshot |
51. | Truqap | capivasertib | 11/16/2023 | To treat breast cancer that meets certain disease criteria |
52. | Ogsiveo | nirogacestat | 11/27/2023 | To treat adults with progressing desmoid tumors who require systemic treatment |
53. | Fabhalta | iptacopan | 12/5/2023 | To treat paroxysmal nocturnal hemoglobinuria |
54. | Filsuvez | birch triterpenes | 12/18/2023 | To treatwounds associated with dystrophic and junctional epidermolysis bullosa |
55. | Wainua | eplontersen | 12/21/2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis Drug Trials Snapshot |