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The FDA ( Food and Drug Administration ) has granted accelerated approval to Polatuzumab vedotin-piiq ( Polivy; Polatuzumab vedotin ), a CD79b-directed antibody-drug conjugate indicated in combination ...


The FDA ( U.S. Food and Drug Administration ) has granted approval to Reblozyl ( Luspatercept–aamt; Luspatercept ) for the treatment of anemia in adult patients with beta-thalassemia who require regul ...


The FDA ( U.S. Food and Drug Administration ) has approved Rybelsus ( Semaglutide ) oral tablets to improve control of blood glucose in adult patients with type 2 diabetes, along with diet and exercis ...


The European Commission ( EC ) has approved Bavencio ( Avelumab ) in combination with Axitinib ( Inlyta ) for the first-line treatment of adult patients with advanced renal cell carcinoma ( RCC ). ...


The European Commission has approved Xeomin ( IncobotulinumtoxinA ) for the symptomatic treatment of chronic sialorrhea due to neurological disorders in adult patients. Xeomin is the first and only n ...


The European Commission ( EC ) has approved the oral once-daily therapy Xospata ( Gilteritinib ) as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia ...


The FDA ( U.S. Food and Drug Administration ) has approved Sunosi ( Solriamfetol ) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive ...


The FDA ( U.S. Food and Drug Administration ) has approved Reyvow ( Lasmiditan ) tablets for the acute treatment of migraine with or without aura ( a sensory phenomenon or visual disturbance ) in adul ...


The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with syste ...


The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir ) tablets for an eight-week duration for the treatment of adults and children ages 12 ...


The European Commission has granted marketing authorization in the European Union ( EU ) for the precision oncology treatment Vitrakvi ( Larotrectinib ). The drug is indicated for the treatment of a ...


The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastat ...


The FDA ( U.S. Food and Drug Administration ) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence ( OCE ). Project Orbis provides a framework for concurrent submissio ...


The European Commission ( EC ) has approved Empliciti ( Elotuzumab ) plus Pomalidomide and low-dose Dexamethasone ( EPd ) for the treatment of adult patients with relapsed and refractory multiple myel ...


The Food and Drug Administration ( FDA ) has approved Nubeqa ( Darolutamide ) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS, a multicenter, double-blind, pla ...