Drugs Xagena
The FDA ( U.S. Food and Drug Administration ) has approved Cablivi ( Caplacizumab-yhdp ) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytop ...
The European Commission ( EC ) has approved Mylotarg ( Gemtuzumab ozogamicin ) in combination with Daunorubicin and Cytarabine for the treatment of patients age 15 years and above with previously untr ...
The U.S. Food and Drug Administration ( FDA ) has approved the 2-mg dose of Olumiant ( Baricitinib ), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheuma ...
The Food and Drug Administration ( FDA ) has approved Lutathera ( Lutetium Lu 177 Dotatate ), a radiolabeled Somatostatin analog, for the treatment of Somatostatin receptor-positive gastroenteropancre ...
The Food and Drug Administration ( FDA ) has approved Hemlibra ( Emicizumab-kxwh; Emicizumab ) injection for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric ...
The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Vitrakvi ( Larotrectinib ), a treatment for adult and pediatric patients whose cancers have a specific genetic feature ...
Menière's disease ( MD ) is an idiopathic pathological condition of the inner ear ( IE ) whose major symptoms are vertigo, fluctuating hearing loss, tinnitus, and fullness. These symptoms are most o ...
The FDA ( U.S. Food and Drug Administration ) has approved Elzonris ( Tagraxofusp-erzs; Tagraxofusp ) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm ( BPDCN ) in adults and ...
The FDA ( U.S. Food and Drug Administration ) has approved Xospata ( Gilteritinib ) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia ( AML ) with a FL ...
The FDA ( U.S. Food and Drug Administration ) has approved the first drug, Oxervate ( Cenegermin ), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea ( the clear layer t ...
The FDA ( Food and Drug Administration ) has approved Cemiplimab-rwlc ( Libtayo, Cemiplimab ) for patients with metastatic cutaneous squamous cell carcinoma ( CSCC ) or locally advanced CSCC who are n ...
FDA ( U.S. Food and Drug Administration ) has approved Inbrija ( Levodopa inhalation powder ) for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with Carbidopa / Le ...
The FDA ( US Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) in combination with Avastin ( Bevacizumab ), Paclitaxel and Carboplatin ( chemotherapy ), for the initial ( first-li ...
The European Commission has approved Delstrigo and Pifeltro for the treatment of HIV-1 infection. Delstrigo is a new once-daily fixed-dose combination tablet of Doravirine ( 100 mg ), Lamivudine ( ...
The FDA ( U.S. Food and Drug Administration ) has approved Larotrectinib ( Vitrakvi ), the first oral TRK inhibitor. The approval is for the treatment of adult and pediatric patients with solid tumor ...
The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, in combination with Carboplatin and either Paclitaxel or nab-Paclitaxel, for the first-line ...
The European Commission has approved Tafinlar ( Dabrafenib ) in combination with Mekinist ( Trametinib ) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma afte ...
The European Commission has approved Keytruda ( Pembrolizumab ), anti-PD-1 therapy, in combination with Pemetrexed ( Alimta ) and Platinum chemotherapy for the first-line treatment of metastatic nonsq ...
The European Commission ( EC ) has granted marketing authorization for Hulio, a biosimilar to Humira ( Adalimumab ), for all indications. The authorization follows the adoption of a positive opinio ...
The FDA ( U.S. Food and Drug Administration ) has approved Lumoxiti ( Moxetumomab pasudotox-tdfk ) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy c ...
The European Commission has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, in combination with Pemetrexed ( Alimta ) and Platinum chemotherapy for the first-line treatment of metastatic no ...
The FDA ( U.S. Food and Drug Administration ) has approved Tibsovo ( Ivosidenib ) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia ( AML ) who have a spec ...
The U.S. Food and Drug Administration ( FDA ) has approved Crysvita ( Burosumab-twza ), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia ( XLH ...
The FDA ( U.S. Food and Drug Administration ) has approved Poteligeo ( Mogamulizumab-kpkc ) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoi ...
The European Commission has granted marketing authorisation for Tagrisso ( Osimertinib ), a third-generation, irreversible EGFR-TKI, as monotherapy for the 1st-line treatment of adult patients with lo ...
Early data from two clinical trials have shown reduced survival with Keytruda ( Pembrolizumab ) and Tecentriq ( Atezolizumab ) when used as first-line treatments for urothelial cancer ( cancer of the ...
The European Commission has approved a label update for the use of once-daily Relvar Ellipta ( Fluticasone furoate / Vilanterol, FF/VI ), an inhaled corticosteroid ( ICS ) / long-acting beta2-agonist ...
The European Commission ( EC ) has approved Cabometyx ( Cabozantinib ) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma ( aRCC ). ...
The Food and Drug Administration ( FDA ) has approved Osimertinib ( Tagrisso ) for the first-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose tumors have epidermal ...
The European Medicines Agency ( EMA ) has approved Lynparza ( Olaparib ) tablets ( 300mg twice daily ) for use as a maintenance therapy for patients with Platinum-sensitive relapsed high-grade, epithe ...
The FDA ( US Food and Drug Administration ) has approved Kisqali ( Ribociclib ) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative ( HR+/HER2- ) advanced or me ...
The U.S. Food and Drug Administration ( FDA ) has approved Tafinlar ( Dabrafenib ) and ( Trametinib ), administered together, for the treatment of anaplastic thyroid cancer ( ATC ) that cannot be remo ...
The European Commission has granted marketing authorisation for Lokelma ( formerly ZS-9, sodium Zirconium cyclosilicate ) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious c ...
The FDA ( U.S. Food and Drug Administration ) has approved Biktarvy ( Bictegravir 50mg / Emtricitabine 200mg / Tenofovir alafenamide 25mg, BIC/FTC/TAF ), a once-daily single tablet regimen ( STR ) for ...
The FDA ( U.S. Food and Drug Administration ) has approved Lutathera ( Lutetium Lu 177 dotatate ) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastr ...
The FDA ( U.S. Food and Drug Administration ) has approved Imfinzi ( Durvalumab ) for the treatment of patients with stage III non-small cell lung cancer ( NSCLC ) whose tumors are not able to be surg ...
The FDA ( U.S. Food and Drug Administration ) has approved Erleada ( Apalutamide ) for the treatment of patients with prostate cancer that has not spread ( non-metastatic ), but that continues to grow ...
The FDA ( U.S. Food and Drug Administration ) has approved Imfinzi ( Durvalumab ) for the treatment of patients with stage III non-small cell lung cancer ( NSCLC ) whose tumors are not able to be surg ...
European Commission ( EC ) has granted marketing authorisation for Ocrevus ( Ocrelizumab ) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and fo ...
The U.S. Food and Drug Administration ( FDA ) has approved Mylotarg ( Gemtuzumab ozogamicin ) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 anti ...
The U.S. Food and Drug Administration ( FDA ) has expanded the approved use of Nucala ( Mepolizumab ) to treat adult patients with eosinophilic granulomatosis with polyangiitis ( EGPA ), a rare autoim ...
On August 1, 2017, the FDA ( U.S. Food and Drug Administration ) has granted regular approval to Idhifa ( Enasidenib ) for the treatment of adult patients with relapsed or refractory acute myeloid leu ...
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Aliqopa ( Copanlisib ) for the treatment of adult patients with relapsed follicular lymphoma who have received at leas ...
The FDA ( U.S. Food and Drug Administration ) has expanded the approved use of Dysport ( AbobotulinumtoxinA ) for injection for the treatment of spasticity in adults, based on its supplemental Biologi ...
The FDA ( U.S. Food and Drug Administration ) has approved Endari ( L-Glutamine oral powder ) for patients age five years and older with sickle cell disease to reduce severe complications associated w ...
The European Commission ( EC ) has approved Fotivda ( Tivozanib ) for the treatment of adult patients with advanced renal cell carcinoma ( RCC ) in the European Union plus Norway and Iceland. Tivoza ...
The FDA ( U.S. Food and Drug Administration ) has approved Nerlynx ( Neratinib ) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cance ...
The European Commission ( EC ) has approved Alecensa ( Alectinib ), a second-generation ALK inhibitor, for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer ( ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Calquence ( Acalabrutinib ) for the treatment of adults with mantle cell lymphoma who have received at least one prior ther ...
The European Commission ( EC ) has granted marketing authorization for Stivarga ( Regorafenib ) for the treatment of adult patients with hepatocellular carcinoma ( HCC ) who have been previously treat ...
