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August 20, 2020

FDA OKs Ofatumumab (Kesimpta) for Relapsing Forms of MS FDA OKs Ofatumumab (Kesimpta) for Relapsing Forms of MS

The US Food and Drug Administration (FDA) has approved ofatumumab injection (Kesimpta, Novartis) for the treatment of adults with relapsing forms of multiple sclerosis, including relapsing-remitting […]
August 14, 2020

FDA Clears Rapid Large-Vessel Occlusion Detection Software FDA Clears Rapid Large-Vessel Occlusion Detection Software

The US Food and Drug Administration (FDA) has granted clearance to the Rapid LVO automated software, which is designed to detect suspected large-vessel occlusions (LVOs). The […]
August 12, 2020

FDA OKs Viltolarsen (Viltepso) for Duchenne Muscular Dystrophy FDA OKs Viltolarsen (Viltepso) for Duchenne Muscular Dystrophy

The US Food and Drug Administration (FDA) has approved viltolarsen (Viltepso, NS Pharma), the second drug therapy for Duchenne muscular dystrophy in patients with a confirmed […]
August 10, 2020

FDA Approves IV Opioid Oliceridine for Short-term Use FDA Approves IV Opioid Oliceridine for Short-term Use

The US Food and Drug Administration (FDA) has approved the intravenous (IV) opioid oliceridine (Olinvyk) for the management of moderate to severe acute pain in adults […]
August 10, 2020

FDA Approves First Liquid Biopsy/NGS Test for Lung Cancer FDA Approves First Liquid Biopsy/NGS Test for Lung Cancer

A new test, the first to combine liquid biopsy and next generation sequencing (NGS), has been approved by the US Food and Drug Administration (FDA) for use […]
August 7, 2020

FDA OKs First Oral Treatment for Spinal Muscular Atrophy FDA OKs First Oral Treatment for Spinal Muscular Atrophy

The US Food and Drug Administration (FDA) has approved risdiplam (Evrysdi, Roche and PTC Therapeutics) for the treatment of adults and children at least 2 months […]
August 6, 2020

FDA Approves Belantamab in R/R Multiple Myeloma FDA Approves Belantamab in R/R Multiple Myeloma

The first-in-class drug belantamab mafodotin (Blenrep) has been granted an accelerated approval by the US Food and Drug Administration (FDA) for use in the treatment of […]
August 5, 2020

FDA Approves Impella for LV Unloading Emergency Use in COVID-19 FDA Approves Impella for LV Unloading Emergency Use in COVID-19

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has granted emergency-use authorization (EUA) […]
August 3, 2020

FDA OKs Two Blood Tests to Estimate SARS-CoV-2 Antibodies FDA OKs Two Blood Tests to Estimate SARS-CoV-2 Antibodies

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has authorized the first two […]
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