Drugs Xagena
The European Commission ( EC ) has approved Rinvoq ( Upadacitinib, 15 mg ), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis ( PsA ) in adult ...
The European Commission ( EC ) has approved the extension of the indication of Invokana ( Canagliflozin ) to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in ...
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 extended the indication of Mylotarg ( Gemtuzumab ozogamicin ) for newly-diagnosed CD33-positive acute myeloid leukemia ( AML ) to include pediatric patient ...
The U.S. Food and Drug Administration ) FDA ) has granted accelerated approval to Tazverik ( Tazemetostat ) for the treatment of adults and pediatric patients aged 16 years and older with metastatic ...
The Food and Drug Administration ( FDA ) hasapproved Sarclisa ( Isatuximab-irfc; Isatuximab ) in combination with Pomalidomide and Dexamethasone for adult patients with multiple myeloma who have recei ...
The FDA ( U.S. Food and Drug Administration ) has approved Tukysa ( Tucatinib ) in combination with chemotherapy ( Capecitabine ) and Trastuzumab for the treatment of adult patients with advanced form ...
The European Commission has approved Sunosi ( Solriamfetol ) to improve wakefulness and reduce excessive daytime sleepiness ( EDS ) in adults with narcolepsy ( with or without cataplexy ) or obstructi ...
The Food and Drug Administration ( FDA ) has approved Margenza ( Margetuximab-cmkb; Margetuximab ) in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive b ...
Vyepti ( Eptinezumab-jjmr; Eptinezumab ) has been approved by the U.S. Food and Drug Administration ( FDA ) for the preventive treatment of migraine. The recommended dose is 100 mg every 3 months; so ...
The European Commission ( EC ) has approved Leqvio ( Inclisiran ) for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. This approval is based on the results of the ORION clin ...
The U.S. Food and Drug Administration ( FDA ) has approved Mycapssa ( Octreotide ) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment wit ...
The U.S. Food and Drug Administration ( FDA ) has approved Crysvita ( Burosumab-twza; Burosumab ) injection to treat patients age two and older with tumor-induced osteomalacia ( TIO ), a rare disease ...
The European Commission ( EC ) has approved Sarclisa ( Isatuximab ) in combination with Pomalidomide and Dexamethasone ( Pom-Dex ) for the treatment of adult patients with relapsed and refractory mult ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Rubraca ( Rucaparib ) for patients with deleterious BRCA mutation ( germline and/or somatic )-associated metastatic castrat ...
The FDA ( U.S. Food and Drug Administration ) has approved Onureg ( Azacitidine 300 mg tablets, CC-486 ) for the continued treatment of adult patients with acute myeloid leukemia ( AML ) who achieved ...
The European Commission ( EC ) has extended the marketing authorization of Alunbrig ( Brigatinib ) to include use as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-p ...
The Food and Drug Administration ( FDA ) has approved the first oral gonadotropin-releasing hormone ( GnRH ) receptor antagonist, Orgovyx ( Relugolix ) for adult patients with advanced prostate cancer ...
The FDA ( U.S. Food and Drug Administration ) has approved Tagrisso ( Osimertinib ) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of ge ...
The U.S. Food and Drug Administration ( FDA ) has approved Gavreto ( Pralsetinib ) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged d ...
The European Commission ( EC ) has granted conditional marketing authorization to Ayvakyt ( Avapritinib ) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastroint ...
The European Commission has approved Zejula ( Niraparib ), an oral, once-daily PARP [ poly(ADP-ribose)polymerase ] inhibitor, as first-line monotherapy maintenance treatment for adult patients with ad ...
Calquence ( Acalabrutinib ), a next-generation selective Bruton’s tyrosine kinase ( BTK ) inhibitor, has been approved in the European Union ( EU ) for the treatment of adult patients with chronic lym ...
The U.S. Food and Drug Administration ( FDA ) has approved Ayvakit ( Avapritinib ) for the treatment of adults with unresectable ( unable to be removed with surgery ) or metastatic gastrointestinal st ...
The European Commission ( EC ) has approved Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) with two cycles of Platinum-based chemotherapy for the first-line treatment of adult patients with metastati ...
The European Commission has approved Tecentriq ( Atezolizumab ) in combination with Avastin ( Bevacizumab ) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma ( ...
Lynparza ( Olaparib ) has been approved in the European Union ( EU ) for patients with metastatic castration-resistant prostate cancer ( mCRPC ) with breast cancer susceptibility gene 1/2 ( BRCA1/2 ) ...
Forxiga ( Dapagliflozin ) has been approved in the European Union ( EU ) for the treatment of symptomatic chronic heart failure ( HF ) with reduced ejection fraction ( HFrEF ) in adults with and witho ...
Post-Finasteride syndrome ( PFS ) is a constellation of serious adverse side effects manifested in clinical symptoms that develop and persist in patients during and/or after discontinuing Finasteride ...
The FDA ( U.S. Food and Drug Administration ) has approved Alunbrig ( Brigatinib ) for adult patients with anaplastic lymphoma kinase-positive ( ALK+ ) metastatic non-small cell lung cancer ( NSCLC ) ...
The FDA ( U.S. Food and Drug Administration ) has provided full approval to Venclexta ( Venetoclax ) in combination with Azacitidine, or Decitabine, or low-dose Cytarabine ( LDAC ) for the treatment ...
Imfinzi ( Durvalumab ) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer ( ES-SCLC ) in combination with a choice of chemotherap ...
The U.S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ) 360 mg every three weeks plus Yervoy ( Ipilimumab ) 1 mg/kg every six weeks ( injections for intravenous use ) for the f ...
The Food and Drug Administration ( FDA ) has granted accelerated approval to Blenrep ( Belantamab mafodotin-blmf; Belantamab mafodotin ) for adult patients with relapsed or refractory multiple myeloma ...
The European Commission ( EC ) has granted marketing authorization for Jyseleca ( Filgotinib 200 mg and 100 mg tablets ), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate t ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Monjuvi ( Tafasitamab-cxix, Tafasitamab ), a CD19-directed cytolytic antibody, indicated in combination with Lenalidomide f ...
The FDA ( Food and Drug Administration ) has approved Gavreto ( Pralsetinib ) for the treatment of adults with metastatic rearranged during transfection ( RET ) fusion-positive non-small cell lung can ...
The Food and Drug Administration ( FDA ) has approved a new fixed-dose combination of Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf ( Phesgo ) for subcutaneous injection for the following indicatio ...
The FDA ( US Food and Drug Administration ) has approved Kesimpta ( Ofatumumab, formerly OMB157 ) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis ( RMS ...
Givlaari is a medicine for treating acute hepatic porphyria in patients aged 12 years or over. Acute hepatic porphyria is a rare genetic condition in which the liver cannot properly produce a substanc ...
The European Commission has granted conditional marketing authorisation for Blenrep ( Belantamab mafodotin ) as monotherapy for the treatment of multiple myeloma in adult patients who have received at ...
The U.S. Food and Drug Administration ( FDA ) has approved Darzalex ( Daratumumab ) in combination with Kyprolis ( Carfilzomib ) and Dexamethasone ( DKd ) for the treatment of adult patients with rela ...
The European Commission has granted conditional marketing authorisation for Rozlytrek ( Entrectinib ) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours ex ...
The U.S. Food and Drug Administration ( FDA ) has approved Tepezza ( Teprotumumab-trbw; Teprotumumab ) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatt ...
The Food and Drug Administration ( FDA ) has approved an oral combination of Decitabine and Cedazuridine ( Inqovi ) for adult patients with myelodysplastic syndromes ( MDS ) including the following: p ...
The Food and Drug Administration ( FDA ) has granted accelerated approval to Tazverik ( Tazemetostat ), an EZH2 inhibitor, for adult patients with relapsed or refractory ( R/R ) follicular lymphoma ( ...
The European Commission ( EC ) has approved Reblozyl ( Luspatercept ) for the treatment of: a) adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodys ...
The FDA ( U.S. Food and Drug Administration ) has approved Koselugo ( Selumetinib ) for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 ( NF1 ), a genetic ...
The FDA ( U.S. Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) in combination with Avastin ( Bevacizumab ) for the treatment of people with unresectable or metastatic hepatocell ...
The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metas ...
