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
2023-12-05ImmunologyFabhaltaApprovalTo treat paroxysmal nocturnal hemoglobinuriaiptacopan
2023-11-27DermatologyOgsiveoApprovalTo treat adults with progressing desmoid tumors who require systemic treatmentnirogacestat
2023-11-16OncologyRyzneutaApprovalTo treat neutropeniaefbemalenograstim alfa-vuxw
2023-11-16OncologyTruqapApprovalTo treat breast cancer that meets certain disease criteriacapivasertib
2023-11-15ImmunologyDefencathApprovalTo reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous cathetertaurolidine, heparin
2023-11-15OncologyAugtyroApprovalTo treat ROS1-positive non-small cell lung cancerrepotrectinib
2023-11-08CardiologyFruzaqlaApprovalTo treat refractory, metastatic colorectal cancerfruquintinib
2023-10-27ImmunologyLoqtorziApprovalTo treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapiestoripalimab-tpzi
2023-10-26PediatricsAgamreeApprovalTo treat Duchenne muscular dystrophyvamorolone
2023-10-26ImmunologyOmvohApprovalTo treat ulcerative colitismirikizumab-mrkz
2023-10-17ImmunologyZilbrysqApprovalTo treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positivezilucoplan
2023-10-17DermatologyBimzelxApprovalTo treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapybimekizumab
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
2023-09-28CardiologyPombilitiApprovalTo treat late-onset Pompe diseasecipaglucosidase alfa-atga
2023-09-22CardiologyExxuaApprovalTo treat major depressive disordergepirone
2023-09-15PediatricsOjjaaraApprovalTo treat intermediate or high-risk myelofibrosis in adults with anemiamomelotinib
2023-09-08OncologyAphexdaApprovalTo use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myelomamotixafortide
2023-08-18ImmunologyVeopozApprovalTo treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE diseasepozelimab-bbfg
2023-08-16DermatologySohonosApprovalTo 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 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
2023-08-04PediatricsZurzuvaeApprovalTo treat postpartum depression Press Releasezuranolone
2023-08-04PediatricsIzervayApprovalTo treat geographic atrophy secondary to age-related macular degenerationavacincaptad pegol
2023-07-25PediatricsXdemvyApprovalTo 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 Press Releasenirsevimab-alip
2023-06-27PediatricsNgenlaApprovalTo treat growth failure due to inadequate secretion of endogenous growth hormonesomatrogon-ghla
2023-06-26ImmunologyRystiggoApprovalTo treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positiverozanolixizumab-noli
2023-06-23OncologyLitfuloApprovalTo treat severely patchy hair lossritlecitinib
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 therapyglofitamab-gxbm
2023-05-26CardiologyInpefaApprovalTo treat heart failuresotagliflozin
2023-05-25OncologyPoslumaApprovalTo use with positron emission tomography imaging in certain patients with prostate cancerflotufolastat F 18
2023-05-25CardiologyPaxlovidApprovalTo treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 Press Releasenirmatrelvir, ritonavir
2023-05-23ImmunologyXacduroApprovalTo treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex Press Releasesulbactam, durlobactam
2023-05-19OncologyEpkinlyApprovalTo 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
2023-05-18MieboApprovalTo treat signs and symptoms of dry eye diseaseperfluorhexyloctane
2023-05-12PediatricsVeozahApprovalTo treat moderate to severe hot flashes caused by menopause Press Releasefezolinetant
2023-05-09ImmunologyElfabrioApprovalTo treat confirmed Fabry diseasepegunigalsidase alfa-iwxj
2023-04-25QalsodyApprovalTo treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutationtofersen
2023-03-24DermatologyJoenjaApprovalTo treat activated phosphoinositide 3-kinase delta syndromeleniolisib
2023-03-22ImmunologyRezzayoApprovalTo treat candidemia and invasive candidiasisrezafungin
2023-03-22EndocrinologyZynyzApprovalTo treat metastatic or recurrent locally advanced Merkel cell carcinomaretifanlimab-dlwr
2023-03-10PediatricsDaybueApprovalTo treat Rett syndrometrofinetide
2023-03-09PediatricsZavzpretApprovalTo treat migrainezavegepant
2023-02-28PediatricsSkyclarysApprovalomaveloxolone
2023-02-17PediatricsFilspariApprovalTo reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progressionsparsentan
2023-02-16ImmunologyLamzedeApprovalTo 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 Press Releasedaprodustat
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 endocelacestrant
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 inhibitorpirtobrutinib
2023-01-20EndocrinologyBrenzavvyApprovalTo improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercisebexagliflozin
2023-01-06PediatricsLeqembiApprovallecanemab-irmb