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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 ...


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 ...