Drugs Xagena
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 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 ...
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 ...
The FDA ( Food and Drug Administration ) has approved Tecartus ( Brexucabtagene autoleucel ) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia ( ALL ). Ef ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Scemblix ( Asciminib ) for patients with Philadelphia chromosome-positive chronic myeloid leukemia ( Ph+ CML ) in chronic p ...
The European Commission ( EC ) has approved Rinvoq ( Upadacitinib ), an oral, selective and reversible JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescent ...
The U.S. Food and Drug Administration ( FDA ) ha approved Opdivo ( Nivolumab ) 240 mg every two weeks or 480 mg every four weeks ( injection for intravenous use ) for the adjuvant treatment of patient ...
The European Commission ( EC ) has approved Ponvory ( Ponesimod ) for the treatment of adult patients with relapsing multiple sclerosis ( RMS ) with active disease defined by clinical or imaging featu ...
The U.S. Food and Drug Administration ( FDA ) has approved the combination of Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, plus Lenvima ( Lenvatinib ), the orally available multiple receptor tyro ...
The FDA ( U.S. Food and Drug Administration ) has approved Kerendia ( Finerenone ), the first non-steroidal, selective mineralocorticoid receptor ( MR ) antagonist. Finerenone 10 mg or 20 mg is indic ...
The U.S. Food and Drug Administration, FDA, has approved Aduhelm ( Aducanumab ) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using ...
The U.S. Food and Drug Administration ( FDA ) has approved Zynlonta ( Loncastuximab tesirine-lpyl; Loncastuximab tesirine ) for the treatment of adult patients with relapsed or refractory ( r/r ) larg ...
The U.S. Food and Drug Administration ( FDA ) has approved Pradaxa ( Dabigatran etexilate ) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism directly after ...
The U.S. Food and Drug Administration ( FDA ) has approved Lumakras ( Sotorasib ) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic ...
Tagrisso ( Osimertinib ), an irreversible epidermal growth factor receptor tyrosine kinase inhibitor ( EGFR TKI ), has been approved in the European Union ( EU ) for the adjuvant treatment of adult pa ...
The Food and Drug Administration ( FDA ) has granted accelerated approval to Zynlonta ( Loncastuximab tesirine-lpyl; Loncastuximab tesirine ), a CD19-directed antibody and alkylating agent conjugate, ...
The European Commission ( EC ) has approved Sarclisa ( Isatuximab ) in combination with Carfilzomib and Dexamethasone ( Kd ) for the treatment of adult patients with relapsed multiple myeloma who have ...
Farxiga ( Dapagliflozin ), a sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate ( eGFR ) decline, end- ...
European Commission has approved Tecentriq ( Atezolizumab ) as a first-line treatment for adults with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have high PD-L1 expression, with no ...
The FDA ( US Food and Drug Administration ) has approved Jemperli ( Dostarlimab-gxly; Dostarlimab ), a programmed death receptor-1 ( PD-1 ) blocking antibody. Dostarlimab is indicated for the treatmen ...
