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July 23, 2021

FDA OKs Extended-Release Exenatide for Children With T2D FDA OKs Extended-Release Exenatide for Children With T2D

The Food and Drug Administration has approved exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for use in children with type 2 diabetes down to 10 years of […]
July 22, 2021

FDA Fully Approves Combination for Advanced Endometrial Cancer FDA Fully Approves Combination for Advanced Endometrial Cancer

The US Food and Drug Administration (FDA) has fully approved the combination of the immunotherapy pembrolizumab (Keytruda) plus the multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) for […]
July 21, 2021

FDA OKs Spinal Cord Stimulation for Diabetic Neuropathy Pain FDA OKs Spinal Cord Stimulation for Diabetic Neuropathy Pain

The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN). The approval is specific for […]
July 19, 2021

FDA Approves Tacrolimus for Lung Transplants FDA Approves Tacrolimus for Lung Transplants

The US Food and Drug Administration (FDA) has approved the use of the transplant drug tacrolimus (Prograf) for the prevention of organ rejection in adult and […]
July 19, 2021

FDA Approves New Drug for Chronic Graft-Versus-Host Disease FDA Approves New Drug for Chronic Graft-Versus-Host Disease

The US Food and Drug Administration (FDA) has granted a full approval for belumosudil (Rezurock) for the treatment of adult and pediatric patients 12 years and […]
July 16, 2021

FDA Warns of Potential Mechanical Concerns With MAGEC Devices FDA Warns of Potential Mechanical Concerns With MAGEC Devices

The US Food and Drug Administration (FDA) has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive. MAGEC is […]
July 2, 2021

Medtronic Vascular Recalls Angiographic Guidewire Component Medtronic Vascular Recalls Angiographic Guidewire Component

Medtronic Vascular has issued a recall for certain models of its Angiographic Guidewire Component, used during angiography and interventional procedures, because the devices weren’t sterilized before […]
July 2, 2021

FDA Approves New Asparaginase Product for Leukemia FDA Approves New Asparaginase Product for Leukemia

The US Food and Drug Administration (FDA) has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase […]
June 30, 2021

FDA OKs 1-Month Dual Antiplatelet Therapy for Abbott’s Xience Stents FDA OKs 1-Month Dual Antiplatelet Therapy for Abbott’s Xience Stents

The US Food and Drug Administration (FDA) has approved 1-month — as short as 28 days — dual antiplatelet therapy (DAPT) labeling for Xience stents in […]
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