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The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval of Trodelvy ( Sacituzumab govitecan-hziy; Sacituzumab govitecan ) for use in adult patients with locally advanced or meta ...


The FDA ( U.S. Food and Drug Administration ) has approved Sarclisa ( Isatuximab ) in combination with Carfilzomib and Dexamethasone ( Kd ), for the treatment of adult patients with relapsed or refrac ...


The FDA ( U.S. Food and Drug Administration ) has approved supplemental New Drug Application ( sNDA ) for Lorbrena ( Lorlatinib ), a tyrosine kinase inhibitor ( TKI ), expanding the indication to incl ...


The U.S. Food and Drug Administration ( FDA ) has approved Ponvory ( Ponesimod ), a once-daily oral selective sphingosine-1-phosphate receptor 1 ( S1P1 ) modulator, to treat adults with relapsing form ...


The FDA ( U.S. Food and Drug Administration ) has approved Darzalex Faspro ( Daratumumab and Hyaluronidase-fihj ), a subcutaneous formulation of Daratumumab, in combination with Bortezomib, Cyclophos ...


The FDA ( U.S. Food and Drug Administration ) has approved the PD-1 inhibitor Libtayo ( Cemiplimab-rwlc; Cemiplimab ) for the first-line treatment of patients with advanced non-small cell lung cancer ...


The European Commission ( EC ) has granted marketing authorization for Tukysa ( Tucatinib ) in combination with Trastuzumab and Capecitabine for the treatment of adult patients with HER2-positive loca ...


The FDA ( US Food and Drug Administration ) has approved the following expanded indication for Entresto ( Sacubitril / Valsartan ): to reduce the risk of cardiovascular death and hospitalization for h ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Ukoniq ( Umbralisib ), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications ...


The FDA ( US Food and Drug Administration ) has approved Tepmetko ( Tepotinib ) for the treatment of adult patients with metastatic non-small cell lung cancer ( NSCLC ) harboring mesenchymal-epithelia ...


The European Commission has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high ( ...


The Food and Drug Administration ( FDA ) has approved Xalkori ( Crizotinib ) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell ...


The European Commission ( EC ) has approved Bavencio ( Avelumab ) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma ( U ...


The FDA ( U.S. Food and Drug Administration ) has approved Opdivo ( Nivolumab ) 240 mg injection for intravenous use every two weeks or 480 mg every four weeks in combination with CaboMetyx ( Cabozant ...


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 ...