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Data for Odronextamab in patients with relapsed / refractory ( R/R ) follicular lymphoma ( FL ) from a pivotal phase 2 trial ( ELM-2 ) were presented at the 65th American Society of Hematology ( ASH ) ...


The U.S. Food and Drug Administration has approved Xacduro ( Sulbactam for injection; Durlobactam for injection ), a new treatment for hospital-acquired bacterial pneumonia ( HABP ) and ventilator-ass ...


The U.S. Food and Drug Administration ( FDA ) has approved Ayvakit ( Avapritinib ) for the treatment of adults with indolent systemic mastocytosis ( ISM ). The approval of Ayvakit in indolent syst ...


The European Commission ( EC ) has granted marketing authorization for Brukinsa ( Zanubrutinib) in combination with Obinutuzumab for the treatment of adult patients with relapsed or refractory ( R/R ...


The European Commission ( EC ) has expanded the marketing authorization for Dupixent ( Dupilumab ) in the European Union ( EU ) to treat eosinophilic esophagitis ( EoE ) in adults and adolescents 12 y ...


The European Commission ( EC ) has granted the approval of a Type II variation application for Tecvayli ( Teclistamab), providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks ...


The European Commission ( EC ) has approved Camzyos ( Mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules ) for the treatment of symptomatic ( NYHA, class II-III ) obstructive hypertrophic cardiomyopathy ...


The U.S. Food and Drug Administration ( FDA ) has approved Talzenna ( Talazoparib ), an oral poly ADP-ribose polymerase ( PARP ) inhibitor, in combination with Enzalutamide, for the treatment of adult ...


The U.S. Food and Drug Administration ( FDA ) has approved Litfulo ( Ritlecitinib ), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Elrexfio ( Elranatamab-bcmm; Elranatamab ) for the treatment of adult patients with relapsed or refractory multiple my ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Epkinly ( Epcoritamab-bysp; Epcoritamab ) for relapsed or refractory diffuse large B-cell lymphoma ( DLBCL ) not otherwise ...


The Food and Drug Administration ( FDA ) has approved Trodelvy ( Sacituzumab govitecan-hziy; Sacituzumab govitecan ) for patients with unresectable locally advanced or metastatic hormone receptor ( HR ...


The European Commission ( EC ) has approved Rinvoq ( Upadacitinib, 45 mg [ induction dose ] and 15 mg and 30 mg [ maintenance doses ] ) as the first oral Janus Kinase ( JAK ) inhibitor for the treatme ...


The U.S. Food and Drug Administration (FDA) has granted Padcev ( Enfortumab vedotin-ejfv; Enfortumab vedotin ) with Pembrolizumab ( Keyrtruda ) accelerated approval in the U.S. as a combination therap ...


The U.S. Food and Drug Administration ( FDA ) has approved Leqembi ( Lecanemab-irmb; Lecanemab ) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second ...


The Food and Drug Administration ( FDA ) has approved Brukinsa ( Zanubrutinib ) for chronic lymphocytic leukemia ( CLL ) or small lymphocytic lymphoma ( SLL ). Efficacy in patients with treatment-n ...


The Food and Drug Administration ( FDA ) has approved Rezlidhia ( Olutasidenib ) capsules for adult patients with relapsed or refractory acute myeloid leukemia ( AML ) with a susceptible IDH1 mutation ...


The European Commission ( EC ) granted marketing authorization for Lorviqua ( Lorlatinib, available in the U.S. under the brand name Lorbrena ) as monotherapy for the treatment of adult patients with ...


The U.S. Food and Drug Administration ( FDA ) has approved Igalmi ( Dexmedetomidine ) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in ...


The U.S. Food and Drug Administration ( FDA ) has approved Olumiant ( Baricitinib ), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata, available as 4- ...


The European Commission ( EC ) has granted marketing authorization for Livtencity ( Maribavir ) for the treatment of cytomegalovirus ( CMV ) infection and/or disease that are refractory ( with or with ...


The Food and Drug Adninistration ( FDA ) has granted accelerated approval for Vonjo ( Pacritinib ) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate or high ...


The Food and Drug Administration ( FDA ) has approved Tremelimumab ( Imjudo ) in combination with Durvalumab ( Imfinzi ) and Platinum-based chemotherapy for adult patients with metastatic non-small ce ...


Tezspire ( Tezepelumab ) has been approved in the European Union ( EU ) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high d ...


The FDA ( U.S. Food and Drug Administration ) has approved Tecvayli ( Teclistamab-cqyv; Teclistamab ) for the treatment of adult patients with relapsed or refractory multiple myeloma, who pr ...


The FDA ( U.S. Food and Drug Administration ) has approved Olumiant ( Baricitinib ), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata ( AA ), availabl ...


The FDA ( Food and Drug Administration ) has granted accelerated approval for Vonjo ( Pacritinib ) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate or high ...


The Food and Drug Administration ( FDA ) has approved Libtayo ( Cemiplimab-rwlc; Cemiplimab ) in combination with Platinum-based chemotherapy for adult patients with advanced non-small cell lung cance ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Krazati ( Adagrasib ), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metast ...


The Food and Drug Administration ( FDA ) has approved Rezlidhia ( Olutasidenib ) capsules for adult patients with relapsed or refractory acute myeloid leukemia ( AML ) with a susceptible IDH1 mutation ...


The Food and Drug Administration ( FDA ) has approved Tremelimumab ( Imjudo ) in combination with Durvalumab for adult patients with unresectable hepatocellular carcinoma ( uHCC ). Efficacy was eva ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Tecvayli ( Teclistamab;Teclistamab-cqyv ), the first bispecific B-cell maturation antigen ( BCMA )-directed CD3 T-cell enga ...


The FDA ( Food and Drug Administration ) has approved the Biologics License Application ( BLA ) for Tzield ( Teplizumab-mzwv; Teplizumab ), an anti-CD3-directed antibody, for intravenous use, as the f ...


The U.S. Food and Drug Administration ( FDA ) has approved Relyvrio ( Sodium Phenylbutyrate / Taurursodiol ) to treat patients with amyotrophic lateral sclerosis ( ALS ), commonly referred to as Lou G ...


The U.S. Food and Drug Administration ( FDA ) has approved a supplemental New Drug Application ( sNDA ) for the oral androgen receptor inhibitor ( ARi ) Darolutamide ( Nubeqa ) in combination with Doc ...


The FDA ( Food and Drug Administration ) has approved Pyrukynd ( Mitapivat ) tablets to treat hemolytic anemia in adults with pyruvate kinase ( PK ) deficiency. PK deficiency is an inherited disord ...


The Food and Drug Administration ( FDA ) has approved Enhertu ( fam-Trastuzumab Deruxtecan-nxki; Trastuzumab Deruxtecan ) for adult patients with unresectable or metastatic HER2-low ( IHC 1+ or IHC 2+ ...


The European Commission ( EC ) has granted conditional marketing authorisation ( CMA ) of Tecvayli ( Teclistamab ) as monotherapy for the treatment of adult patients with relapsed and refractory multi ...


The European Commission ( EC ) has granted conditional marketing authorization for Minjuvi ( Tafasitamab ) in combination with Lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult ...


The FDA ( Food and Drug Administration ) has approved Opzelura ( Ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is a ...


The U.S. Food and Drug Administration ( FDA ) has approved Tibsovo ( Ivosidenib ) in combination with Azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemi ...


The U.S. Food and Drug Administration ( FDA ) has approved Mounjaro ( Tirzepatide ) injection to improve blood glucose control in adults with type 2 diabetes, as an addition to diet and exercise. Mo ...


The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion recommending approval of a new treatment option with Ibrutinib ( Imbr ...


The European Commission ( EC ) has granted conditional marketing authorisation for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio ( Mosunetuzumab ), for the treatment of adult patients with ...


The European Commission ( EC ) has granted approval of Polivy ( Polatuzumab vedotin ) in combination with Rituximab plus Cyclophosphamide, Doxorubicin, and Prednisone ( R-CHP ) for the treatment of ad ...


The U.S. Food and Drug Administration ( FDA ) has approved Mounjaro ( Tirzepatide ) injection to improve blood glucose control in adults with type 2 diabetes, as an addition to diet and exercise. Mo ...


The European Commission has granted marketing authorization for the intravenous ( IV ) formulation of Entyvio ( Vedolizumab ) for the treatment of adult patients with moderately to severely active chr ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Vijoice ( Alpelisib ) for the treatment of adult and pediatric patients 2 years of age and older with severe manifesta ...


The European Commission ( EC ) has approved Opdivo ( Nivolumab ) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression 1% or more who are at a ...


The Committee for Medicinal Products for Human Use ( CHMP ), the scientific Committee of the European Medicines Agency ( EMA ), adopted a positive opinion for the use of Quviviq ( Daridorexant ) as th ...