2024-04-17 | Oncology | Lumisight | Approval | To use as an optical imaging agent for the detection of cancerous tissue | pegulicianine |
2024-04-03 | Immunology | Zevtera | Approval | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="7456646c-bc7d-4e1c-84db-9591b9e7842b" href="https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses" title="FDA Approves New Antibiotic for Three Different Uses">Press Release</a> | ceftobiprole medocaril sodium |
2024-03-29 | | Voydeya | Approval | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria | danicopan |
2024-03-27 | Gastroenterology | Vafseo | Approval | To treat anemia due to chronic kidney disease | vadadustat |
2024-03-26 | Family Medicine | Winrevair | Approval | To treat pulmonary arterial hypertension | sotatercept-csrk |
2024-03-21 | Pediatrics | Duvyzat | Approval | To treat Duchenne muscular dystrophy in individuals aged 6 years and older<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="39e18b71-9941-4b15-a4b5-98ec0a9c8f38" href="https://www.fda.gov/news-events/press-announcements/fda-approves-nonsteroidal-treatment-duchenne-muscular-dystrophy" title="FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy">Press Release</a> | givinostat |
2024-03-19 | Family Medicine | Tryvio | Approval | To treat hypertension | aprocitentan |
2024-03-14 | Gastroenterology | Rezdiffra | Approval | To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="25eb6b83-6d1b-4645-80ff-cd11ea0f599b" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease" title="FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease">Press Release</a> | resmetirom |
2024-03-13 | Anesthesiology | Tevimbra | Approval | To treat unresectable or metastatic esophageal squamous cell carcinoma | tislelizumab-jsgr |
2024-02-29 | Cardiology | Letybo | Approval | To temporarily improve the appearance of moderate-to-severe glabellar lines<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="630419dc-060e-4b76-b552-97efbd05f7e2" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-letybo" title="Drug Trials Snapshots: LETYBO">Drug Trials Snapshot</a> | letibotulinumtoxinA-wlbg |
2024-02-22 | Immunology | Exblifep | Approval | To treat complicated urinary tract infections | cefepime, enmetazobactam |
2024-01-05 | Dermatology | Zelsuvmi | Approval | To treat molluscum contagiosum | berdazimer |
2023-12-21 | Dermatology | Wainua | Approval | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="068baddd-a37c-4201-9262-a22e6b848078" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-wainua" title="Drug Trials Snapshots: WAINUA">Drug Trials Snapshot</a> | eplontersen |
2023-12-18 | Dermatology | Filsuvez | Approval | To treat wounds associated with dystrophic and junctional epidermolysis bullosa | birch triterpenes |
2023-12-05 | Immunology | Fabhalta | Approval | To treat paroxysmal nocturnal hemoglobinuria | iptacopan |
2023-11-27 | Dermatology | Ogsiveo | Approval | To treat adults with progressing desmoid tumors who require systemic treatment | nirogacestat |
2023-11-16 | Family Medicine | Truqap | Approval | To treat breast cancer that meets certain disease criteria | capivasertib |
2023-11-16 | Oncology | Ryzneuta | Approval | To treat neutropenia<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="05a1a1c5-0dcc-4c67-b9c7-6c576b7fb3ef" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ryzneuta" title="Drug Trials Snapshots: RYZNEUTA">Drug Trials Snapshot</a> | efbemalenograstim alfa-vuxw |
2023-11-15 | Orthopedic Surgery | Augtyro | Approval | To treat ROS1-positive non-small cell lung cancer | repotrectinib |
2023-11-15 | Gastroenterology | Defencath | Approval | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter | taurolidine, heparin |
2023-11-08 | Gastroenterology | Fruzaqla | Approval | To treat refractory, metastatic colorectal cancer | fruquintinib |
2023-10-27 | Internal Medicine | Loqtorzi | Approval | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies | toripalimab-tpzi |
2023-10-26 | Immunology | Omvoh | Approval | To treat ulcerative colitis | mirikizumab-mrkz |
2023-10-26 | Pediatrics | Agamree | Approval | To treat Duchenne muscular dystrophy<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="306dc327-8d2d-4b23-b33a-ab9a001c7ae4" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-agamree" title="Drug Trials Snapshots: AGAMREE">Drug Trials Snapshot</a> | vamorolone |
2023-10-17 | Dermatology | Bimzelx | Approval | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="368f41a2-98c0-46cb-ba80-b27eff93dca7" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-bimzelx" title="Drug Trials Snapshots: BIMZELX">Drug Trials Snapshot</a> | bimekizumab |
2023-10-17 | Immunology | Zilbrysq | Approval | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive | zilucoplan |
2023-10-12 | Cardiology | Velsipity | Approval | To treat moderately to severely active ulcerative colitis in adults | etrasimod |
2023-09-29 | Pediatrics | Rivfloza | Approval | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | nedosiran |
2023-09-28 | Family Medicine | Pombiliti | Approval |
<p>To treat late-onset Pompe disease<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="fab1d510-2baf-40fe-a5cf-b4ec373424cd" href="https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-pombiliti" title="Drug Trials Snapshots: POMBILITI ">Drug Trials Snapshot</a></p>
| cipaglucosidase alfa-atga |
2023-09-22 | Family Medicine | Exxua | Approval | To treat major depressive disorder | gepirone |
2023-09-15 | Oncology | Ojjaara | Approval | To treat intermediate or high-risk myelofibrosis in adults with anemia | momelotinib |
2023-09-08 | Anesthesiology | Aphexda | Approval | 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<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="b02013d9-d47a-4e0b-92bf-6907f94c95a0" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-aphexda" title="Drug Trials Snapshots: APHEXDA">Drug Trials Snapshot</a> | motixafortide |
2023-08-18 | Immunology | Veopoz | Approval | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease | pozelimab-bbfg |
2023-08-16 | Family Medicine | Sohonos | Approval | 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 | palovarotene |
2023-08-14 | Immunology | Elrexfio | Approval | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy | elranatamab-bcmm |
2023-08-09 | Dermatology | Talvey | Approval | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies | talquetamab-tgvs |
2023-08-04 | Family Medicine | Izervay | Approval | To treat geographic atrophy secondary to age-related macular degeneration | avacincaptad pegol |
2023-08-04 | Family Medicine | Zurzuvae | Approval | To treat postpartum depression <br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="7ea80c50-27f5-47ec-ad60-4cd84fe301c8" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression" title="FDA Approves First Oral Treatment for Postpartum Depression">Press Release</a> | zuranolone |
2023-07-25 | Family Medicine | Xdemvy | Approval | To treat Demodex blepharitis | lotilaner |
2023-07-20 | Cardiology | Vanflyta | Approval | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria | quizartinib |
2023-07-17 | Pediatrics | Beyfortus | Approval | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="040ddc36-f2da-4ecd-87da-40e8d7632997" href="https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers" title="FDA Approves New Drug to Prevent RSV in Babies and Toddlers">Press Release</a><br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="7c2720b6-f663-4f6f-8891-33c9a356ea78" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-beyfortus" title="Drug Trials Snapshots: BEYFORTUS">Drug Trials Snapshot</a> | nirsevimab-alip |
2023-06-27 | Pediatrics | Ngenla | Approval | To treat growth failure due to inadequate secretion of endogenous growth hormone<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="8b312439-d8da-429c-b91a-675106f3ac5e" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ngenla" title="Drug Trials Snapshots: NGENLA">Drug Trials Snapshot</a> | somatrogon-ghla |
2023-06-26 | Immunology | Rystiggo | Approval | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive | rozanolixizumab-noli |
2023-06-23 | Dermatology | Litfulo | Approval | To treat severely patchy hair loss<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="99b723e3-d813-412b-857a-145774a0ce7b" href="https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo" title="Drug Trials Snapshots: LITFULO">Drug Trials Snapshot</a> | ritlecitinib |
2023-06-15 | Oncology | Columvi | Approval | 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<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="74444ae7-912d-49c5-96b6-35ac8bb0b85f" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-columvi" title="Drug Trials Snapshots: COLUMVI">Drug Trials Snapshot</a> | glofitamab-gxbm |
2023-05-26 | Cardiology | Inpefa | Approval |
<p>?To treat heart failure </p>
| sotagliflozin |
2023-05-25 | Oncology | Posluma | Approval | To use with positron emission tomography imaging in certain patients with prostate cancer<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="bbfb6d81-12f7-4c5b-bfae-b2c02ae5de0a" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-posluma" title="Drug Trials Snapshot: POSLUMA">Drug Trials Snapshot</a> | flotufolastat F 18 |
2023-05-25 | Family Medicine | Paxlovid | Approval | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="ea7e719b-c9ca-4aab-aa8c-354d132f76d3" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults" title="FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults">Press Release</a><br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="a1fac31d-9f56-4af4-b08a-97f14071d916" href="https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-paxlovid" title="Drug Trials Snapshots: PAXLOVID">Drug Trials Snapshot</a> | nirmatrelvir, ritonavir |
2023-05-23 | Immunology | Xacduro | Approval |
<p>To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of <em>Acinetobacter baumannii-calcoaceticus complex</em><br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="c61a578e-4ca9-4fef-b519-04e0707967da" href="https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria" title="FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria">Press Release</a></p>
| sulbactam, durlobactam |
2023-05-19 | Anesthesiology | Epkinly | Approval | 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 | epcoritamab-bysp |
2023-05-18 | Ophthalmology | Miebo | Approval | To treat signs and symptoms of dry eye disease | perfluorhexyloctane |
2023-05-12 | Anesthesiology | Veozah | Approval | To treat moderate to severe hot flashes caused by menopause<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="56edc76f-3f9a-4513-a449-421b879db9de" href="https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause" title="FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause">Press Release</a> | fezolinetant |
2023-05-09 | Family Medicine | Elfabrio | Approval | To treat confirmed Fabry disease | pegunigalsidase alfa-iwxj |
2023-04-25 | Anesthesiology | Qalsody | Approval | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation | tofersen |
2023-03-24 | Family Medicine | Joenja | Approval | To treat activated phosphoinositide 3-kinase delta syndrome | leniolisib |
2023-03-22 | Family Medicine | Rezzayo | Approval | To treat candidemia and invasive candidiasis | rezafungin |
2023-03-22 | Internal Medicine | Zynyz | Approval | To treat metastatic or recurrent locally advanced Merkel cell carcinoma | retifanlimab-dlwr |
2023-03-10 | Pediatrics | Daybue | Approval | To treat Rett syndrome | trofinetide |
2023-03-09 | Neurology | Zavzpret | Approval | To treat migraine | zavegepant |
2023-02-28 | Pediatrics | Skyclarys | Approval | To treat Friedrich's ataxia<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="d5d47e0f-b00b-4f6a-a2a3-a73ee44e8169" href="https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-skyclarys" title="Drug Trials Snapshots: SKYCLARYS">Drug Trials Snapshots</a> | omaveloxolone |
2023-02-17 | Family Medicine | Filspari | Approval | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | sparsentan |
2023-02-16 | Family Medicine | Lamzede | Approval | To treat non-central nervous system manifestations of alpha-mannosidosis | velmanase alfa-tycv |
2023-02-01 | Cardiology | Jesduvroq | Approval | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="b1e79f3d-5e0f-4390-835c-6454080d42f7" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis" title="FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis">Press Release</a><br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="9c25982c-9cf8-4c2a-9959-d0eb31c0ee09" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-jesduvroq" title="Drug Trials Snapshots: JESDUVROQ">Drug Trials Snapshot</a> | daprodustat |
2023-01-27 | Oncology | Orserdu | Approval | 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<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="acd9f643-afb0-413b-938f-9b9a2de647fb" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-orserdu" title="Drug Trials Snapshots: ORSERDU">Drug Trials Snapshot</a> | elacestrant |
2023-01-27 | Oncology | Jaypirca | Approval | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="040de04e-a583-4bbc-9f2c-c7b8b3ad4bbe" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-jaypirca" title="Drug Trials Snapshots: JAYPIRCA">Drug Trials Snapshot</a> | pirtobrutinib |
2023-01-20 | Endocrinology | Brenzavvy | Approval | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise<br><a style="color:#0080c0;" data-entity-type="node" data-entity-uuid="7298d9e4-04a6-4f1f-8112-2bf6ffe1933a" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-brenzavvy" title="Drug Trials Snapshots: BRENZAVVY">Drug Trials Snapshot</a> | bexagliflozin |
2023-01-06 | Neurology | Leqembi | Approval | | lecanemab-irmb |