Drugs Xagena
The Food and Drug Administration ( FDA ) has approved Itovebi ( Inavolisib ), with Palbociclib and Fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, huma ...
The European Medicines Agency ( EMA ) has recommended the approval of Truqap ( Capivasertib ) in combination with Fulvestrant for the treatment of patients with estrogen receptor (ER)–positive, HER2‑n ...
The European Commission ( EC ) has approved Talzenna ( Talazoparib ), an oral poly ADP-ribose polymerase ( PARP ) inhibitor, in combination with Enzalutamide ( Xtandi ), for the treatment of adult pat ...
The U.S. Food and Drug Administration ( FDA ) has approved Rezdiffra ( Resmetirom ) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis ( NASH ) with moderate to advanced liver ...
FDA ( Food and Drug Administration ) has approved Joenja ( Leniolisib ) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years o ...
The Food and Drug Administration ( FDA ) has approved Truqap ( Capivasertib ) with Fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-n ...
The European Medicines Agency (EMA) has recommended the conditional marketing authorization ( CMA ) of Futibatinib ( Lytgobi ) for the treatment of adult patients with locally advanced or metastatic c ...
The FDA ( Food and Drugs Administration ) has approved Augtyro ( Repotrectinib ), an oral tyrosine kinase inhibitor ( TKI ) targeting ROS1 oncogenic fusions, for the treatment of locally advanced or m ...
The U.S. Food and Drug Administration ( FDA ) has approved Zynyz ( Retifanlimab-dlwr; Retifanlimab ), a humanized monoclonal antibody targeting programmed death receptor-1 ( PD-1 ), for the treatment ...
The European Commission ( EC ) has approved Inaqovi ( oral Decitabine and Cedazuridine ) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia ( AML ) who are ...
The U.S. Food and Drug Administration ( FDA ) has approved Talzenna ( Talazoparib ), an oral poly ADP-ribose polymerase ( PARP ) inhibitor, in combination with Enzalutamide ( Xtandi ), for the treatme ...
The Food and Drug Administration ( FDA ) has approved Loqtorz ( Toripalimab-tpzi; Toripalimab ) with Cisplatin and Gemcitabine for the first-line treatment of adults with metastatic or recurrent, loca ...
The European Commission ( EC ) has approved Trodelvy ( Sacituzumab govitecan ) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2 ...
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 ...
An updated analysis of the phase 3 ADAURA trial did not find any new safety signals and no deterioration in health-related quality of life ( HRQOL ) following treatment with Osimertinib ( Tagrisso ) a ...
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 Polivy ( Polatuzumab vedotin-piiq; Polatuzumab vedotin ) with a Rituximab product, Cyclophosphamide, Doxorubicin, and Prednisone ( R-CHP ) for adu ...
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 Lytgobi ( Futibatinib ) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepat ...
The European Commission ( EC ) has approved Pluvicto [ Lutetium ( 177Lu ) vipivotide tetraxetan ], a targeted radioligand therapy. Pluvicto is approved in combination with androgen deprivation thera ...
The European Commission has approved Tepmetko ( Tepotinib ) for use as a single agent in adult patients with advanced non-small cell lung cancer ( NSCLC ) harboring METex14 skipping alterations who re ...
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 ...
