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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 ( 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 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 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 ...