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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 […]
June 29, 2021

EU Green Light for Roxadustat in Anemia of Kidney Disease EU Green Light for Roxadustat in Anemia of Kidney Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the use of roxadustat (Evrenzo, […]
June 25, 2021

Pfizer Pauses Distribution of Stop-Smoking Pill Chantix Pfizer Pauses Distribution of Stop-Smoking Pill Chantix

Pfizer is suspending distribution of the anti-smoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills. The […]
June 22, 2021

FDA Approves OTC Antihistamine Nasal Spray FDA Approves OTC Antihistamine Nasal Spray

The US Food and Drug Administration (FDA) has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal […]
June 18, 2021

FDA Approves StrataGraft for Deep Skin Burns FDA Approves StrataGraft for Deep Skin Burns

The US Food and Drug Administration (FDA) has approved a novel regenerative therapy that could be an alternative to autografting for treating adults with severe burns. […]
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