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The US Food and Drug Administration (FDA) approved a wide range of therapies in 2023, including many new molecular entities and biological products. The information below is organized by the month in which the product received approval.
January 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Endocrine Disorders | |||
| Brenzavvy (bexagliflozin) | Sodium-glucose cotransporter 2 inhibitor | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. | Brenzavvy Approved for Adults With Type 2 Diabetes |
| Neurologic Disorders | |||
| Leqembi (lecanemab-irmb) | Amyloid beta-directed antibody. | Treatment of Alzheimer disease. | Leqembi Drug Monograph |
| Oncology | |||
| Brukinsa (zanubrutinib) | Small molecule inhibitor of Bruton tyrosine kinase | For the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. | Brukinsa Drug Monograph |
| Jaypirca (pirtobrutinib) | Noncovalent inhibitor of BTK | Treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a BTK inhibitor. | Jaypirca Approved for Relapsed/Refractory Mantle Cell Lymphoma |
| Keytruda (pembrolizumab) | Programmed death receptor-1 blocking antibody | For adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB, II, or IIIA non-small cell lung cancer. | Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC |
| Orserdu (elacestrant) | Estrogen receptor antagonist | Treatment of postmenopausal women or adult men with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy. | Orserdu Approved for ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer |
| Tukysa (tucatinib) | Tyrosine kinase inhibitor | In combination with trastuzumab for the treatment of adults with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. | Tukysa Drug Monograph |
| Psychiatric Disorders | |||
| Rykindo (risperidone) | Atypical antipsychotic | Treatment of schizophrenia in adults, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. | Rykindo Approved for Schizophrenia, Bipolar Disorder |
February 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Hematological Disorders | |||
| Altuviiio (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) | Recombinant DNA-derived, Factor VIII concentrate | Routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with hemophilia A. | Altuviiio Approved as Once-Weekly Factor VIII Therapy for Hemophilia A |
| Kidney Disease | |||
| Filspari (sparsentan) | Endothelin and angiotensin II receptor antagonist | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. | Filspari Granted Accelerated Approval to Reduce Proteinuria in IgA Nephropathy |
| Jesduvroq (daprodustat) | Oral hypoxia-inducible factor prolyl hydroxylase inhibitor | Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 4 months. | Jesduvroq Approved for Anemia of CKD in Patients on Dialysis |
| Metabolic Disorders | |||
| Lamzede (velmanase alfa-tycv) | Recombinant form of human lysosomal alpha-mannosidase | Treatment of noncentral nervous system manifestations of alpha-mannosidosis. | Lamzede Approved for Noncentral Nervous System Manifestations of Alpha-Mannosidosis |
| Musculoskeletal Disorder | |||
| Kevzara (sarilumab) | Interleukin-6 receptor antagonist | Treatment of adults with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. | Kevzara Approved for Polymyalgia Rheumatica |
| Skyclarys (omaveloxolone) | Activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway | Treatment of Friedreich ataxia in patients 16 years of age and older. | Skyclarys Approved for Friedreich Ataxia |
| Oncology | |||
| Trodelvy (sacituzumab govitecan-hziy) | Trop-2 directed antibody and topoisomerase inhibitor conjugate. | For the treatment of adults with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. | Trodelvy Drug Monograph |
| Ophthalmic Disorders | |||
| Eylea (aflibercept) | Vascular endothelial growth factor inhibitor | Treatment of preterm infants with retinopathy of prematurity. | Eylea Drug Monograph |
| Syfovre (pegcetacoplan injection) | Complement inhibitor | Treatment of geographic atrophy secondary to age-related macular degeneration. | Syfovre Drug Monograph |
March 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Neurologic Disorders | |||
| Daybue (trofinetide) | Synthetic analogue of glycine-proline-glutamate | Treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. | FDA Greenlights Daybue for Treatment of Rett Syndrome |
| Oncology | |||
| Verzenio (abemaciclib) | Kinase inhibitor | In combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence. | Verzenio Drug Monograph |
| Tafinlar (dabrafenib) + Mekinist (trametinib) | Kinase inhibitors | Treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. | Tafinlar + Mekinist Approved for Pediatric BRAF V600E Low-Grade Glioma |
| Zynyz (retifanlimab-dlwr) | Programmed death receptor-1-blocking antibody | Treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. | Zynyz Approved for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma |
| Pain Management | |||
| Zavzpret (zavegepant) | Calcitonin gene-related peptide receptor antagonist | Treatment of migraine with or without aura in adults. | Zavzpret Nasal Spray Approved for Acute Treatment of Migraine |
| Immune Disorders | |||
| Joenja (leniolisib) | Selective PI3Kδ inhibitor | Treatment of activated phosphoinositide 3-kinase delta syndrome in patients 12 years of age and older. | Joenja Approved for Activated Phosphoinositide 3-Kinase Delta Syndrome |
| Infectious Disease | |||
| Rezzayo (rezafungin for injection) | Echinocandin antifungal | Treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. | FDA Approves Antifungal Rezzayo for Patients With Limited Treatment Options |
April 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Dermatologic Disorders | |||
| Brella 3-Minute Sweat Control Patch | Single-use disposable patch consists of a sodium sheet | Treatment of primary axillary hyperhidrosis. | FDA Clears Patch Therapy to Reduce Excessive Underarm Sweating in Adults |
| Endocrine Disorders | |||
| Sogroya (somapacitan-beco) | Human growth hormone analog | Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. | Once-Weekly Sogroya Approved for Pediatric Growth Hormone Deficiency |
| Oncology | |||
| Padcev (enfortumab vedotin-ejfv) + Keytrude (pembrolizumab) | Nectin-4 directed antibody-drug conjugate and programmed death receptor-1 blocking antibody | First-line treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-containing chemotherapy. | Padcev Plus Keytruda Approved as First-Line Treatment for Urothelial Cancer |
| Polivy (polatuzumab vedotin-piiq) |
CD79b-directed antibody and microtubule inhibitor conjugate.
|
In combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater. | Polivy Combination Therapy Approved for Previously Untreated DLBCL |
| Omisirge (omidubicel-onlv) | Nicotinamide modified allogeneic hematopoietic progenitor cell therapy | Treatment of patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. | FDA Approves Omisirge, an Allogeneic Cell Therapy for Patients With Blood Cancers |
| Immunization | |||
| Prevnar 20 (20-valent pneumococcal conjugate vaccine) |
Capsular antigens of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F
|
The prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes in infants and children 6 through 17 years of age, and for the prevention of otitis media caused by 7 of the 20 Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in infants and children 6 weeks through 5 years of age. | FDA Approves Prevnar 20 Vaccine for Use in Infants and Children |
| Infectious Disease | |||
| Vowst (fecal microbiota spores, live-brpk) | Purified bacterial spores of multiple Firmicute species | To prevent the recurrence of C. difficile (CDI) infection in adults 18 years of age and older following antibacterial treatment for recurrent CDI. | Vowst Approved to Prevent Recurrent C. difficile Infection |
| Neurologic Disorders | |||
| Qalsody (tofersen) | Antisense oligonucleotide | Treatment of adults with amyotrophic lateral sclerosis who have a mutation in the superoxide dismutase 1 gene. | Qalsody Approved for SOD1 Amyotrophic Lateral Sclerosis |
| Pain Management | |||
| Qulipta (atogepant) | Calcitonin gene-related peptide receptor antagonist | Preventive treatment of chronic migraine in adults. | Qulipta Approval Expanded to Include Preventive Treatment of Chronic Migraine |
| Psychiatric Disorders | |||
| Abilify Asimtufii (aripiprazole extended-release injectable suspension) | Atypical antipsychotic | Treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults. | Abilify Asimtufii Approved for Schizophrenia, Bipolar I Disorder |
| Uzedy (risperidone) | Atypical antipsychotic | Treatment of schizophrenia in adults. | Uzedy, Long-Acting Schizophrenia Treatment, Gets FDA Approval |
May 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Cardiovascular Disease | |||
| Farxiga (dapagliflozin) | Sodium-glucose cotransporter 2 inhibitor | To reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visit in adults with HF regardless of left ventricular ejection fraction status. | Farxiga Approval Expands Use to More Patients With Heart Failure |
| Inpefa (sotagliflozin) | Sodium-glucose cotransporter 2 inhibitor | To reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (HF), and urgent HF visit in adults with HF; or with type 2 diabetes mellitus, chronic kidney disease, and other CV risk factors. | FDA Approves Inpefa for the Treatment of Heart Failure |
| Diagnostic Agents | |||
| Posluma (flotufolastat F 18) | Radiohybrid PSMA-targeted receptor ligand | For positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer, with suspected metastasis who are candidates for initial definitive therapy; or with suspected recurrence based on elevated serum prostate-specific antigen level. | PSMA-Targeted Imaging Agent Posluma Approved to Aid in Prostate Cancer Detection |
| Dermatological Disorders | |||
| Vyjuvek (beremagene geperpavec-svdt) | Herpes-simplex virus type 1 vector-based gene | Treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain gene. | Topical Gene Therapy Vyjuvek Approved for Dystrophic Epidermolysis Bullosa |
| Gastroenterology | |||
| Rinvoq (upadacitinib) | Janus kinase (JAK) inhibitor | Treatment of adults with moderately to severely active Crohn disease who have had an inadequate response or intolerance to 1 or more tumor necrosis factor blockers. | Rinvoq Approved for Moderately to Severely Active Crohn Disease |
| Hematological Disorders | |||
| Ayvakit (avapritinib) | Tyrosine kinase inhibitor | Treatment of adults with indolent systemic mastocytosis. | Ayvakit Approved for Indolent Systemic Mastocytosis |
| Obstetrics and Gynecology | |||
| Veozah (fezolinetant) | Neurokinin 3 receptor antagonist | Treatment of moderate to severe vasomotor symptoms due to menopause. | Veozah Approved for Moderate to Severe Vasomotor Symptoms Due to Menopause |
| Oncology | |||
| Epkinly (epcoritamab-bysp) |
Immunoglobulin G1-bispecific antibody | Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after 2 or more lines of systemic therapy. | Epkinly Approved for Relapsed, Refractory Diffuse Large B-Cell Lymphoma |
| Ophthalmic Disorders | |||
| Miebo (perfluorohexyloctane ophthalmic solution) | Semifluorinated alkane | Treatment of the signs and symptoms of dry eye disease. | Miebo Approved to Treat Signs and Symptoms of Dry Eye Disease |
| Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) | Anticholinergic + alpha-1 adrenergic receptor agonist | To induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. | Fixed-Dose Combo Mydcombi Ophthalmic Spray Approved to Induce Mydriasis |
| Immunization | |||
| Abrysvo (respiratory syncytial virus [RSV] vaccine) | Unadjuvanted bivalent vaccine containing recombinant RSV prefusion F (preF) A and RSV preF B | For the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. | RSV Vaccine Abrysvo Approved for Individuals 60 Years and Older |
| Arexvy (RSV vaccine, adjuvanted) | Recombinant RSV glycoprotein F stabilized in pre-fusion conformation as the antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component |
For active immunization for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. |
RSV Vaccine Arexvy Wins FDA Approval for Older Adults |
| Infectious Disease | |||
| Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) | SARS-CoV-2 main protease inhibitor + HIV-1 protease inhibitor and CYP3A inhibitor | Treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. | Paxlovid Receives FDA Approval for COVID-19 Treatment |
| Xacduro (sulbactam for injection; durlobactam for injection) | Beta-lactam antibacterial and beta lactamase inhibitor | Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. | Xacduro Gets FDA Approval for Pneumonia Caused by Acinetobacter |
| Metabolic Disorders | |||
| Elfabrio (pegunigalsidase alfa-iwxj) | Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme | Treatment of adults with confirmed Fabry disease. | Elfabrio Approved for Adults With Fabry Disease |
| Neurologic Disorders | |||
| Lumryz (sodium oxybate) | Central nervous system depressant | Treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. | FDA Approves Once-Nightly Lumryz for Patients With Narcolepsy |
June 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Cardiovascular Disease | |||
| Injectafer (ferric carboxymaltose injection) | Iron replacement product | Treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity | Injectafer Approved for Iron Deficiency in Adults With Heart Failure |
| Lodoco (colchicine) | Alkaloid | To reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular (CV) death in adult patients with established atherosclerotic disease or with multiple risk factors for CV disease. | Lodoco Approved to Reduce Risk of Cardiac Events in Patients With Cardiovascular Disease |
| Dermatological Disorders | |||
| RECELL System | Autologous cell harvesting device | Treatment of vitiligo. | RECELL System Cleared for Skin Repigmentation in Patients With Vitiligo |
| Endocrine Disorders | |||
| Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) | Sodium-glucose co-transporter 2 inhibitor | Adjuncts to diet and exercise to improve glycemic control in children 10 years of age and older with type 2 diabetes mellitus. | Empagliflozin Approved for Pediatric Patients With Type 2 Diabetes |
| Lantidra (donislecel-jujn) | Allogeneic pancreatic islet cellular therapy | Treatment of type 1 diabetes in adults who are unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. | FDA Approves Lantidra, a Cellular Therapy for Type 1 Diabetes |
| Ngenla (somatrogon-ghla) | Human growth hormone analog | Treatment of pediatric patients 3 years of age and older who have growth failure due to inadequate secretion of endogenous growth hormone. | Once-Weekly Ngenla Approved for Pediatric Growth Hormone Deficiency |
| Gastrohepatic Disorders | |||
| Linzess (linaclotide) | Guanylate cyclase-C agonist | Treatment of functional constipation in patients 6 to 17 years. | Linzess Approved for Pediatric Functional Constipation |
| Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) | Osmotic laxative | For cleansing of the colon in preparation for colonoscopy in adults. | Suflave, a Low-Volume, Colonoscopy Preparation, Gets FDA Approval |
| Hematological Disorders | |||
| Roctavian (valoctocogene roxaparvovec-rvox) | Adeno-associated virus vector-based gene therapy | Treatment of adults with severe hemophilia A without preexisting antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test. | FDA Greenlights Gene Therapy Roctavian for Severe Hemophilia A |
| Infectious Disease | |||
| Prevymis (letermovir) | CMV DNA terminase complex inhibitor | For prophylaxis of cytomegalovirus disease in adult kidney transplant recipients at high risk. | Prevymis Approved for CMV Disease Prevention in Kidney Transplant Recipients |
| Metabolic Disorders | |||
| Bylvay (odevixibat) | Ileal bile acid transporter inhibitor | Treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome. | Bylvay Approved for Cholestatic Pruritus Due to Alagille Syndrome |
| Musculoskeletal Disorders | |||
| Elevidys (delandistrogene moxeparvovec-rokl) | Adeno-associated virus vector-based gene therapy | Treatment of ambulatory pediatric patients 4 to 5 years of age with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene. | Elevidys, a Gene Therapy for Duchenne Muscular Dystrophy, Gets FDA Approval |
| Rystiggo (rozanolixizumab-noli) | Humanized monoclonal antibody that binds with high affinity to human neonatal Fc receptor | Treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. | FDA Approves Rystiggo for Generalized Myasthenia Gravis |
| Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | Neonatal Fc receptor blocker and endoglycosidase combination | Treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. | SC Injectable Vyvgart Hytrulo Gets FDA Nod for Generalized Myasthenia Gravis |
| Oncology | |||
| Blincyto (blinatumomab) |
Bispecific CD19-directed CD3 T-cell engager
|
Treatment of patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1%. | Blincyto Granted Full Approval for MRD-Positive B-Cell Precursor ALL |
| Columvi (glofitamab-gxbm) |
CD20xCD3 T-cell engaging bispecific antibody | Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after 2 or more lines of systemic therapy. | Columvi Approved for Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| Talzenna (talazoparib) |
Poly (ADP-ribose) polymerase inhibitor
|
Treatment of adult patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer. | Talzenna Combo Approved for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer |
| Ophthalmic Disorders | |||
| Vevye (cyclosporine ophthalmic solution) | Calcineurin inhibitor | Treatment of the signs and symptoms of dry eye disease. | Water-Free Dry Eye Disease Therapy Vevye Gets FDA Approval |
July 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Cardiovascular Disease | |||
| Balfaxar (prothrombin complex concentrate, human-lans) | Prothrombin complex concentrate containing the coagulation factors II, VII, IX, and X and antithrombotic proteins C and S | For the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients with need for an urgent surgery or invasive procedures. | Balfaxar Approved for Warfarin Reversal in Urgent Surgery, Invasive Procedures |
| Leqvio (inclisiran) | Small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 messenger RNA | Treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, to reduce low-density lipoprotein cholesterol, as an adjunct to diet and statin therapy. | Leqvio Indication Updated to Include Use in More Patients for LDL-C Reduction |
| Dermatological Disorders | |||
| Ycanth (cantharidin) | Vesicant | Treatment of molluscum contagiosum. | Ycanth, a Drug-Device Combo for Molluscum Contagiosum, Gets Approval |
| Infectious Disease | |||
| Cyfendus (anthrax vaccine absorbed, adjuvanted) | Cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of B. anthracis | For postexposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age. | Anthrax Vaccine Cyfendus Approved for Postexposure Prophylaxis |
| Veklury (remdesivir) | SARS-CoV-2 nucleotide analog RNA polymerase inhibitor | Treatment of COVID-19 in patients with severe renal impairment, including those on dialysis. | COVID-19 Antiviral Veklury Approved for Use in Patients With Severe Renal Impairment |
| Neurologic Disorders | |||
| Leqembi (lecanemab-irmb) | Amyloid beta-directed monoclonal antibody | Treatment of Alzheimer disease. | Leqembi Granted Traditional Approval for Alzheimer Disease |
| Ob/Gyn | |||
| Opill (norgestral) | Progestin | For the prevention of pregnancy. | First Over-the-Counter Birth Control Pill Gets FDA Approval |
| Oncology | |||
| Jemperli (dostarlimab) |
Programmed death receptor-1-blocking antibody
|
Treatment of adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high. | Jemperli Plus Chemo Approved for dMMR/MSI-H Advanced or Recurrent Endometrial Cancer |
| Vanflyta (quizartinib) |
Highly potent type II FLT3 inhibitor
|
Treatment of adults with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication positive as detected by an FDA-approved test. | Vanflyta Approved for FLT3-ITD Positive Acute Myeloid Leukemia |
| Ophthalmic Disorders | |||
| Xdemvy (lotilaner ophthalmic solution) | Gamma-aminobutyric acid-gated chloride channel inhibitor | Treatment of Demodex blepharitis. | Xdemvy Approved for Treatment of Demodex Blepharitis |
| Poisoning and Drug Dependence | |||
| RiVive (naloxone HCI) | Opioid antagonist | Emergency treatment of known or suspected opioid overdose. | Over-the-Counter RiVive Approved for Treatment of Opioid Overdose |
| Respiratory Disorders | |||
| Beyfortus (nirsevimab-alip) | Long-acting anti-RSV monoclonal antibody | For the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. | Beyfortus Approved to Prevent RSV Disease in Infants and Toddlers |
August 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Hematologic Disorders | |||
| Reblozyl (luspatercept-aamt) | Erythroid maturation agent | Treatment of anemia in adults with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions and are erythropoiesis stimulating agent-naïve. | Reblozyl Approved as First-Line Treatment for Anemia in Lower-Risk Myelodysplastic Syndromes |
| Immunization | |||
| Abrysvo (respiratory syncytial virus vaccine) | RSV vaccine | For pregnant individuals to prevent RSV disease in infants. | RSV Vaccine Abrysvo Approved for Use During Pregnancy to Protect Infants |
| Musculoskeletal Disorders | |||
| Daxxify (daxibotulinumtoxinA-lanm) | Acetylcholine release inhibitor and neuromuscular blocking agent | Treatment of cervical dystonia in adults. | Daxxify Approved for Cervical Dystonia Treatment |
| Ilaris (canakinumab) | Interleukin-1 beta blocker | Treatment of adult patients with gout flares in whom nonsteroidal anti-inflammatory drugs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate. | Ilaris Approval Expanded to Include Treatment of Gout Flares |
| Sohonos (palovarotene) | Retinoid | Reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva. | Sohonos Approved for Fibrodysplasia Ossificans Progressiva |
| Neurologic Disorders | |||
| Ingrezza (valbenazine) | Vesicular monoamine transporter 2 inhibitor | Treatment of adults with chorea associated with Huntington disease. | Ingrezza Gains Approval for Huntington Disease Chorea |
| Tyruko (natalizumab-sztn) | Integrin receptor antagonist | Treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. For inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn disease. | FDA Approves Biosimilar Tyruko for Multiple Sclerosis, Crohn Disease |
| Oncology | |||
| Akeega (niraparib and abiraterone acetate) |
Poly (ADP-ribose) polymerase (PARP) inhibitor plus CYP17 inhibitor
|
Treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved test. | Akeega, an Oral Combo Therapy for BRCA-Mutated mCRPC, Gets FDA Approval |
| Elrexfio (elranatamab-bcmm) |
B-cell maturation antigen-CD3-directed bispecific antibody
|
Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. | FDA Grants Accelerated Approval to Elrexfio for Relapsed/Refractory Multiple Myeloma |
| Hepzato Kit (melphalan/Hepatic Delivery System) |
Alkylating drug
|
Liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. | Hepzato Kit Approved for Unresectable Hepatic-Dominant Metastatic Uveal Melanoma |
| Lonsurf (trifluridine/tipiracil) |
Nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor
|
In combination with bevacizumab for the treatment of adults with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. | Lonsurf Plus Bevacizumab Approved for Metastatic Colorectal Cancer |
| Talvey (talquetamab-tgvs) |
Bispecific G protein-coupled receptor class C group 5 member D-directed CD3 T-cell engager
|
Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. | Talvey Gets Accelerated Approval for Difficult-to-Treat Multiple Myeloma |
| Ophthalmic Disorders | |||
| Eylea HD (aflibercept) | Vascular endothelial growth factor inhibitor | Treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. | Eylea HD Approved for Wet AMD, Diabetic Macular Edema, Diabetic Retinopathy |
| Izervay (avacincaptad pegol intravitreal solution) | PEGylated oligonucleotide that binds to and inhibits complement protein C5 | Treatment of geographic atrophy secondary to age-related macular degeneration. | Izervay Approved for Geographic Atrophy Secondary to AMD |
| Psychiatric Disorders | |||
| Zurzuvae (zuranolone) | Gamma-aminobutyric acid-A receptor positive allosteric modulator | Treatment of postpartum depression. | FDA Approves Zurzuvae, an Oral Treatment for Postpartum Depression |
September 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Infectious Diseases | |||
| Likmez (metronidazole oral suspension) | Nitroimidazole | Treatment of trichomoniasis caused by Trichomonas vaginalis in adults, acute intestinal amebiasis and amebic liver abscess in adults and pediatric patients, and serious infections caused by susceptible anaerobic bacteria in adults. | FDA Approves Likmez Metronidazole Oral Suspension |
| Metabolic Disorders | |||
| Pombiliti (cipaglucosidase alfa-atga) plus Opfolda (miglustat) | Hydrolytic lysosomal glycogen-specific enzyme plus enzyme stabilizer | Treatment of late-onset Pompe disease in patients weighing at least 40kg and who are not improving on their current enzyme replacement therapy. | Pombiliti Plus Opfolda Approved for Late-Onset Pompe Disease |
| Musculoskeletal Disorders | |||
| Tofidence (tocilizumab-bavi) | Interleukin-6 receptor antagonist | Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs; treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; and treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. | FDA Approves Tofidence, the First Biosimilar to Tocilizumab |
| Nephrology | |||
| Jardiance (empagliflozin) | Sodium-glucose co-transporter 2 inhibitor | To reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression. | Jardiance Approved for Adults With Chronic Kidney Disease |
| Oncology | |||
| Aphexda (motixafortide) |
Hematopoietic stem cell mobilizer
|
In combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. | Aphexda Approved for Stem Cell Mobilization for ASCT in Multiple Myeloma |
| Bosulif (bosutinib) |
Tyrosine kinase inhibitor
|
Treatment of patients 1 year of age and older with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. | Bosulif Approved for Pediatric Patients With Chronic Phase Ph+ CML |
| Ojjaara (momelotinib) |
Kinase inhibitor
|
Treatment of intermediate or high-risk myelofibrosis, including primary MF or secondary MF (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia. | Ojjaara Approved for Intermediate or High-Risk Myelofibrosis With Anemia |
| Ophthalmic Disorders | |||
| Ryzumvi (phentolamine ophthalmic solution, 0.75%) | Nonselective alpha-1 and alpha-2 adrenergic antagonist | Treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents. | Ryzumvi Approved for Reversal of Pharmacologically-Induced Mydriasis |
| Psychiatric Disorders | |||
| Exxua (gepirone hydrochloride extended-release tablets) | Selective agonist activity at 5HT1A receptors | Treatment of major depressive disorder in adults. | Exxua, a Novel Treatment for Major Depressive Disorder, Gets FDA Approval |
October 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Dermatological Disorders | |||
| Bimzelx (bimekizumab-bkzx) | Interleukin-17A and F antagonist | Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. | FDA Approves Bimzelx for Moderate to Severe Plaque Psoriasis |
| Cabtreo (clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1%) | Lincosamide antibacterial, retinoid, and an oxidizing agent | Treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. | Cabtreo, a Triple Combo Topical Gel for Acne, Gets FDA Approval |
| Cosentyx (secukinumab) | Interleukin 17-A antagonist | Treatment of moderate to severe hidradenitis suppurativa. | Cosentyx Approved for Moderate to Severe Hidradenitis Suppurativa |
| Wezlana (ustekinumab-auub) | Interleukin-12 and -23 antagonist | Treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn disease, and moderately to severely active ulcerative colitis. In children 6 years of age and older, Wezlana is approved for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, and for active psoriatic arthritis. | Interchangeable Biosimilar Wezlana Gets FDA Approval |
| Endocrine Disorders | |||
| Zituvio (sitagliptin) | Dipeptidyl peptidase-4 inhibitor | Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | Zituvio Receives FDA Approval for Type 2 Diabetes Mellitus |
| Gastrohepatic Disorders | |||
| Omvoh (mirikizumab-mrkz) | Interleukin-23 antagonist | Treatment of moderately to severely active ulcerative colitis in adults. | Omvoh, a Novel Treatment for Ulcerative Colitis, Receives FDA Approval |
| Velsipity (etrasimod) | Sphingosine 1-phosphate receptor modulator | Treatment of moderately to severely active ulcerative colitis. | FDA Approves Velsipity, an Oral Therapy for Ulcerative Colitis in Adults |
| Zymfentra (infliximab-dyyb) |
Tumor necrosis factor blocker
|
Treatment of adults with moderately to severely active ulcerative colitis or Crohn disease following treatment with an infliximab product administered intravenously. | Zymfentra, a Subcutaneous Formulation of Infliximab, Approved for IBD |
| Immunization | |||
| Penbraya (meningococcal groups A, B, C, W and Y vaccine) | Pentavalent meningococcal vaccine | For active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age. | Pentavalent Meningococcal Vaccine Penbraya Gets FDA Approval |
| Musculoskeletal Disorders | |||
| Agamree (vamorolone) | Corticosteroid | Treatment of Duchenne muscular dystrophy in patients 2 years of age and older. | Agamree Approved for Duchenne Muscular Dystrophy |
| Zilbrysq (zilucoplan) | Macrocyclic peptide inhibitor of complement component 5 | Treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. | Zilbrysq Gets FDA Approval for Generalized Myasthenia Gravis |
| Nephrology | |||
| Rivfloza (nedosiran) | Lactate dehydrogenase A-directed small interfering RNA | To lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 and relatively preserved kidney function. | Rivfloza Approved for Patients With Primary Hyperoxaluria Type 1 |
| Xphozah (tenapanor) | Phosphate absorption inhibitor | To reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. | Xphozah Approved for Hyperphosphatemia in CKD Patients on Dialysis |
| Oncology | |||
| Braftovi (encorafenib) |
Kinase inhibitor
|
In combination with binimetinib for the treatment of adults with metastatic non-small cell lung cancer with a BRAF V600E mutation. | Braftovi Plus Mektovi Approved for BRAF V600E Mutation-Positive Metastatic NSCLC |
| Keytruda (pembrolizumab) |
Programmed death receptor-1 blocking antibody
|
Treatment of patients with resectable non-small cell lung cancer in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. | Keytruda Approved as Neoadjuvant/Adjuvant Treatment for Resectable NSCLC |
| Loqtorzi (toripalimab-tpzi) |
Programmed death receptor-1 blocking antibody
|
First-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. | Loqtorzi Approved for Recurrent or Metastatic Nasopharyngeal Carcinoma |
| Opdivo (nivolumab) |
Programmed death receptor-1 blocking antibody
|
Adjuvant treatment of patients 12 years of age and older with completely resected stage IIB or stage IIC melanoma. | Opdivo Approved for Patients With Completely Resected Stage IIB/C Melanoma |
| Rozlytrek (entrectinib) |
Kinase inhibitor
|
Pediatric patients 1 month of age and older with solid tumors, that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. | Rozlytrek Approved for Younger Patients With NTRK Gene Fusion-Positive Solid Tumors |
| Tibsovo (ivosidenib) |
Isocitrate dehydrogenase-1 inhibitor.
|
Treatment of adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test. | Tibsovo Approved for IDH1-Mutated Relapsed/Refractory Myelodysplastic Syndromes |
| Ophthalmic Disorders | |||
| Vabysmo (faricimab-svoa) | Vascular endothelial growth factor and angiopoietin-2 inhibitor | Treatment of macular edema following retinal vein occlusion. | Vabysmo Approved for Macular Edema Following Retinal Vein Occlusion |
| Qlosi (pilocarpine hydrochloride ophthalmic solution) | Cholinergic muscarinic agonist | Treatment of presbyopia in adults. | FDA Approves Qlosi for the Treatment of Presbyopia in Adults |
| Pain Management | |||
| Combogesic (acetaminophen and ibuprofen) | Analgesic/antipyretic and NSAID | Treatment of postoperative pain. | FDA Approves Nonopioid Combination Therapy for Postoperative Pain |
November 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Cardiovascular Disorders | |||
| Adzynma (ADAMTS13, recombinant-krhn) | Human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” | Prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura. | Adzynma Approved for Congenital Thrombotic Thrombocytopenic Purpura |
| Gastrohepatic Disorders | |||
| Voquezna (vonoprazan) | Potassium-competitive acid blocker | Healing and maintenance of healing, of all grades of erosive esophagitis, and relief of heartburn associated with erosive esophagitis in adults. | Voquezna Approved for Erosive Esophagitis and Associated Heartburn |
| Hematologic Disorders | |||
| Ryzneuta (efbemalenograstim alfa-vuxw) | Non-pegylated granulocyte colony-stimulating factor | To decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. | Ryzneuta Approved for Chemotherapy-Induced Neutropenia |
| Immunization | |||
| Ixchiq (chikungunya vaccine, live) | Live-attenuated, single-dose vaccine | For active immunization in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. | FDA Grants Accelerated Approval to Chikungunya Vaccine Ixchiq |
| Infectious Diseases | |||
| DefenCath (taurolidine and heparin) | Thiadiazinane antimicrobial and an anticoagulant | To reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. | DefenCath Approved to Prevent Catheter-Related Bloodstream Infections in Dialysis Patients |
| Metabolic Disorders | |||
| Zepbound (tirzepatide) | Glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist. | Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30kg/m2 or greater (obesity); or 27kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition. | Zepbound Approved for Chronic Weight Management |
| Musculoskeletal Disorders | |||
| Ogsiveo (nirogacestat) | Gamma secretase inhibitor | For adult patients with progressing desmoid tumors who require systematic treatment. | FDA Approves Ogsiveo for Adults With Desmoid Tumors |
| Oncology | |||
| Augtyro (repotrectinib) |
Tyrosine kinase inhibitor
|
Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. | Augtyro Approved for Locally Advanced or Metastatic ROS1-Positive NSCLC |
| Fruzaqla (fruquintinib) |
Kinase inhibitor
|
Treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor therapy, and, if RAS wild‑type and medically appropriate, an anti-epidermal growth factor receptor therapy. | Fruzaqla Approved for Patients With Refractory Metastatic Colorectal Cancer |
| Keytruda (pembrolizumab) |
Programmed death receptor-1 blocking antibody
|
In combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. | Keytruda Plus Chemotherapy Approved for Biliary Tract Cancer |
| Truqap (capivasertib) |
Kinase inhibitor
|
In combination with fulvestrant for the treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer with 1 or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. | Truqap Plus Fulvestrant Approved for HR-Positive Advanced Breast Cancer |
| Xtandi (enzalutamide) |
Androgen receptor inhibitor
|
Treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. | Xtandi Gains Approval for Nonmetastatic Castration-Sensitive Prostate Cancer |
December 2023
Drug |
Pharmacologic Class |
Indication |
More Information |
| Dermatological Disorders | |||
| Filsuvez (birch triterpenes) | Botanical drug product (birch bark extract) | Topical gel for the treatment of partial thickness wounds in patients 6 months of age and older with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. | Filsuvez Topical Gel Approved for Junctional and Dystrophic Epidermolysis Bullosa |
| Zoryve (roflumilast) | Phosphodiesterase type 4 inhibitor | Treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. | Zoryve Topical Foam Approved for Seborrheic Dermatitis |
| Hematological Disorders | |||
| Alvaiz (eltrombopag) | Thrombopoietin receptor agonist | Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding; thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. It should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy; severe aplastic anemia in adults who have had an insufficient response to immunosuppressive therapy. | Alvaiz Approved for ITP, Thrombocytopenia With Hep C, and Severe Aplastic Anemia |
| Casgevy (exagamglogene autoemcel) | CRISPR/Cas9 gene-edited therapy | Cell-based gene therapy for the treatment of sickle cell disease in patients 12 years of age and older. | FDA Approves Gene Therapies Casgevy, Lyfgenia for Sickle Cell Disease |
| Fabhalta (iptacopan) | Factor B inhibitor | Treatment of adults with paroxysmal nocturnal hemoglobinuria. | Fabhalta Approved for Paroxysmal Nocturnal Hemoglobinuria |
| Lyfgenia (lovotibeglogene autoemcel) | Hematopoietic stem cell-based gene therapy | Cell-based gene therapy for the treatment of sickle cell disease in patients 12 years of age and older. | FDA Approves Gene Therapies Casgevy, Lyfgenia for Sickle Cell Disease |
| Wilate (von Willebrand factor/factor VIII complex [human]) | Replacement therapy | Approval expanded to include routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease. | Wilate Approved for Routine Prophylaxis in Von Willebrand Disease |
| Immune Disorders | |||
| Alyglo (immune globulin intravenous, human-stwk) | Neutralizing immunoglobulin G antibodies | Treatment of primary humoral immunodeficiency in adult patients 17 years of age and older. | Alyglo Approved for Patients With Primary Humoral Immunodeficiency |
| Kidney Disease | |||
| Tarpeyo (budesonide) | Glucocorticoid | To reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy who are at risk for disease progression. | Tarpeyo Approved to Reduce Loss of Kidney Function in IgA Nephropathy |
| Metabolic Disorders | |||
| Wainua (eplontersen) | Transthyretin-directed antisense oligonucleotide | Treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. | Wainua Approved for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis |
| Oncology | |||
| Iwilfin (eflornithine) |
Ornithine decarboxylase inhibitor
|
To reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. | Iwilfin, an Oral Maintenance Therapy for High-Risk Neuroblastoma, Gets FDA Approval |
| Jaypirca (pirtobrutinib) |
Bruton tyrosine kinase inhibitor
|
Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a BCL-2 inhibitor. | Jaypirca Gains CLL/SLL Indication Through Accelerated Approval Pathway |
| Keytruda (pembrolizumab) |
Programmed death receptor-1 blocking antibody
|
In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer. | Keytruda Plus Padcev Approved for Locally Advanced or Metastatic Urothelial Cancer |
| Welireg (belzutifan) |
Hypoxia-inducible factor inhibitor
|
Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor. | Welireg Approved for Advanced Renal Cell Carcinoma |
| Ophthalmic Disorders | |||
| iDose TR (travoprost intracameral implant) |
Prostaglandin analog
|
To induce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. | FDA Approves Travoprost Intracameral Implant for Glaucoma, Ocular Hypertension |
