approves

FDA approves olaparib/abiraterone combination for BRCA+ metastatic castration-resistant prostate cancer

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The FDA has approved olaparib (Lynparza) plus abiraterone and prednisone or prednisolone for the treatment of patients with deleterious or suspected BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an accompanying FDA-approved diagnostic test.1 The regulatory decision is supported by results from the Phase 3 PROpel study (NCT03732820) in which the olaparib regimen significantly improved … Read more

FDA approves Yuflyma as Adalimumab’s ninth biosimilar

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The US Food and Drug Administration (FDA) has approved the biosimilar adalimumab-aaty (Yuflyma) in a highly concentrated citrate-free formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States. Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing … Read more