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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 ...


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 ...