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August 26, 2020

FDA Pulls Amputation Boxed Warning Off Canagliflozin Label FDA Pulls Amputation Boxed Warning Off Canagliflozin Label

The US Food and Drug Administration (FDA) has removed the boxed warning about the risk of leg and foot amputations for canagliflozin (Invokana, Invokamet, Janssen), a […]
August 24, 2020

FDA Clears First Brain Stimulation Device to Help Smokers Quit FDA Clears First Brain Stimulation Device to Help Smokers Quit

The US Food and Drug Administration (FDA) has granted marketing approval for the BrainsWay deep transcranial magnetic stimulation (TMS) system to help adult smokers kick tobacco. […]
August 24, 2020

U.S. FDA Authorizes Use of Blood Plasma to Treat Coronavirus U.S. FDA Authorizes Use of Blood Plasma to Treat Coronavirus

WASHINGTON (Reuters) – The U.S. Food & Drug Administration (FDA) on Sunday said it authorized the use of blood plasma from patients who have recovered from […]
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 […]
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