Drug Approvals

Drugs which have gone through the regulatory process ensuring their safety and efficacy.

Date Updated Category Drug Name Drug Status Drug Description Drug Active Ingredient
2024-04-17OncologyLumisightApprovalTo use as an optical imaging agent for the detection of cancerous tissuepegulicianine
2024-04-03ImmunologyZevteraApprovalTo 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>&nbsp;ceftobiprole medocaril sodium
2024-03-29VoydeyaApprovalTo treat extravascular hemolysis&nbsp;with paroxysmal nocturnal hemoglobinuriadanicopan
2024-03-27GastroenterologyVafseoApprovalTo treat anemia due to chronic kidney diseasevadadustat
2024-03-26Family MedicineWinrevairApprovalTo treat pulmonary arterial hypertensionsotatercept-csrk
2024-03-21PediatricsDuvyzatApprovalTo treat Duchenne muscular dystrophy&nbsp;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
2024-03-19Family MedicineTryvioApprovalTo treat hypertensionaprocitentan
2024-03-14GastroenterologyRezdiffraApprovalTo 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
2024-03-13AnesthesiologyTevimbraApprovalTo treat unresectable or metastatic esophageal squamous cell carcinomatislelizumab-jsgr
2024-02-29CardiologyLetyboApprovalTo 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
2024-02-22ImmunologyExblifepApprovalTo treat complicated urinary tract infectionscefepime, enmetazobactam
2024-01-05DermatologyZelsuvmiApprovalTo treat molluscum contagiosumberdazimer
2023-12-21DermatologyWainuaApprovalTo 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
2023-12-18DermatologyFilsuvezApprovalTo treat&nbsp;wounds associated with dystrophic and junctional epidermolysis bullosabirch triterpenes
2023-12-05ImmunologyFabhaltaApprovalTo treat paroxysmal nocturnal hemoglobinuriaiptacopan
2023-11-27DermatologyOgsiveoApprovalTo treat adults with progressing desmoid tumors who require systemic treatmentnirogacestat
2023-11-16Family MedicineTruqapApprovalTo treat breast cancer that meets certain disease criteriacapivasertib
2023-11-16OncologyRyzneutaApprovalTo 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
2023-11-15Orthopedic SurgeryAugtyroApprovalTo treat ROS1-positive non-small cell lung cancerrepotrectinib
2023-11-15GastroenterologyDefencathApprovalTo reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous cathetertaurolidine, heparin
2023-11-08GastroenterologyFruzaqlaApprovalTo treat refractory, metastatic colorectal cancerfruquintinib
2023-10-27Internal MedicineLoqtorziApprovalTo treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapiestoripalimab-tpzi
2023-10-26ImmunologyOmvohApprovalTo treat ulcerative colitismirikizumab-mrkz
2023-10-26PediatricsAgamreeApprovalTo 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
2023-10-17DermatologyBimzelxApprovalTo treat moderate to severe&nbsp;plaque psoriasis&nbsp;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
2023-10-17ImmunologyZilbrysqApprovalTo&nbsp;treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positivezilucoplan
2023-10-12CardiologyVelsipityApprovalTo treat moderately to severely active ulcerative colitis in adultsetrasimod
2023-09-29PediatricsRivflozaApprovalTo lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney functionnedosiran
2023-09-28Family MedicinePombilitiApproval <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
2023-09-22Family MedicineExxuaApprovalTo treat major depressive disordergepirone
2023-09-15OncologyOjjaaraApprovalTo treat&nbsp;intermediate or high-risk myelofibrosis in adults with anemiamomelotinib
2023-09-08AnesthesiologyAphexdaApprovalTo 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
2023-08-18ImmunologyVeopozApprovalTo treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE diseasepozelimab-bbfg
2023-08-16Family MedicineSohonosApprovalTo 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 progressivapalovarotene
2023-08-14ImmunologyElrexfioApprovalTo treat&nbsp;adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapyelranatamab-bcmm
2023-08-09DermatologyTalveyApprovalTo treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapiestalquetamab-tgvs
2023-08-04Family MedicineIzervayApprovalTo treat geographic atrophy secondary to age-related macular degenerationavacincaptad pegol
2023-08-04Family MedicineZurzuvaeApprovalTo treat postpartum depression&nbsp;<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
2023-07-25Family MedicineXdemvyApprovalTo treat Demodex blepharitislotilaner
2023-07-20CardiologyVanflytaApprovalTo use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteriaquizartinib
2023-07-17PediatricsBeyfortusApprovalTo 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
2023-06-27PediatricsNgenlaApprovalTo 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
2023-06-26ImmunologyRystiggoApprovalTo treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positiverozanolixizumab-noli
2023-06-23DermatologyLitfuloApprovalTo 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
2023-06-15OncologyColumviApprovalTo 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
2023-05-26CardiologyInpefaApproval <p>?To treat heart failure&nbsp;</p> sotagliflozin
2023-05-25OncologyPoslumaApprovalTo 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
2023-05-25Family MedicinePaxlovidApprovalTo 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
2023-05-23ImmunologyXacduroApproval <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
2023-05-19AnesthesiologyEpkinlyApprovalTo 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 therapyepcoritamab-bysp
2023-05-18OphthalmologyMieboApprovalTo treat signs and symptoms of dry eye diseaseperfluorhexyloctane
2023-05-12AnesthesiologyVeozahApprovalTo 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
2023-05-09Family MedicineElfabrioApprovalTo treat confirmed Fabry diseasepegunigalsidase alfa-iwxj
2023-04-25AnesthesiologyQalsodyApprovalTo treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutationtofersen
2023-03-24Family MedicineJoenjaApprovalTo treat activated phosphoinositide 3-kinase delta syndromeleniolisib
2023-03-22Family MedicineRezzayoApprovalTo treat candidemia and invasive candidiasisrezafungin
2023-03-22Internal MedicineZynyzApprovalTo treat metastatic or recurrent locally advanced Merkel cell carcinomaretifanlimab-dlwr
2023-03-10PediatricsDaybueApprovalTo treat Rett syndrometrofinetide
2023-03-09NeurologyZavzpretApprovalTo treat migrainezavegepant
2023-02-28PediatricsSkyclarysApprovalTo 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
2023-02-17Family MedicineFilspariApprovalTo reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progressionsparsentan
2023-02-16Family MedicineLamzedeApprovalTo treat non-central nervous system manifestations of alpha-mannosidosisvelmanase alfa-tycv
2023-02-01CardiologyJesduvroqApprovalTo 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
2023-01-27OncologyOrserduApprovalTo 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
2023-01-27OncologyJaypircaApprovalTo 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
2023-01-20EndocrinologyBrenzavvyApprovalTo 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
2023-01-06NeurologyLeqembiApprovallecanemab-irmb