Drugs Xagena
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 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 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 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 ...
The European Commission has granted marketing authorization in the European Union ( EU ) for Finerenone under the brand name Kerendia. Kerendia ( 10 mg or 20 mg ), a non-steroidal, selective mineral ...
The U.S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ) 360 mg ( injection for intravenous use ) in combination with Platinum-doublet chemotherapy every three weeks for three c ...
The European Commission ( EC ) has granted marketing authorization for Jardiance ( Empagliflozin ), an oral, once-daily, highly selective sodium-glucose cotransporter 2 ( SGLT2 ), as a treatment for a ...
The European Commission ( EC ) has granted conditional marketing authorization for Lumykras ( Sotorasib ), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell ...
The Food and Drug Administration ( FDA ) has approved Welireg ( Belzutifan ), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau ( VHL ) disease who require therapy for ass ...
The U.S. Food and Drug Administration ( FDA ) has approved Exkivity ( Mobocertinib ) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) with e ...
FDA has approved Kerendia ( Finerenone ) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart fai ...
Imcivree is a medicine used to treat obesity and help control hunger caused by certain genetic conditions that affect how the brain controls feelings of hunger. It is used in adults and children aged ...
The US Food and Drug Administration ( FDA ) has approved Nucala ( Mepolizumab ), a monoclonal antibody that targets interleukin-5 ( IL-5 ), as a treatment for patients with chronic rhinosinusitis with ...
The U.S. Food and Drug Administration ( FDA ) has approved Vyvgart ( Efgartigimod ) for the treatment of generalized myasthenia gravis ( gMG ) in adults who test positive for the anti-acetylcholine re ...
The FDA ( U.S. Food and Drug Administration ) has granted the accelerated approval of Rybrevant ( Amivantamab-vmjw; Amivantamab ) for the treatment of adult patients with locally advanced or metastati ...
The Food and Drug Administration ( FDA ) has granted accelerated approval to Truseltiq ( Infigratinib ), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metasta ...
The U.S. Food and Drug Administration ( FDA ) has approved the expansion of the Kyprolis ( Carfilzomib ) prescribing information to include its use in combination with Darzalex Faspro ( Daratumumab an ...
FDA ( Food and Drug Administration ) has approved Leqvio ( Inclisiran ) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial ...
The U.S. Food and Drug Administration ( FDA ) has issued an emergency use authorization ( EUA ) for Pfizer’s Paxlovid ( Nirmatrelvir tablets and Ritonavir tablets, co-packaged for oral use ) for the t ...
