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June 28, 2022

FDA Class 1 Recall: Batteries for CARESCAPE 2860 Ventilator FDA Class 1 Recall: Batteries for CARESCAPE 2860 Ventilator

The US Food and Drug Administration (FDA) has issued a Class I Recall for the CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator batteries. A total of 1533 complaints […]
June 28, 2022

FDA Approves Qsymia for Treating Teens With Obesity FDA Approves Qsymia for Treating Teens With Obesity

The US Food and Drug Administration (FDA) has approved a supplemental indication for the combination phentermine and topiramate extended-release capsules (Qsymia, Vivus LLC) in patients aged […]
June 28, 2022

Upadacitinib Recommended for Nonradiographic AxSpA in Europe Upadacitinib Recommended for Nonradiographic AxSpA in Europe

Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use gave it […]
June 27, 2022

FDA Okays Liso-cel for Second Line in Large B-cell Lymphoma FDA Okays Liso-cel for Second Line in Large B-cell Lymphoma

Lisocabtagene maraleucel, also known as liso-cel (Breyanzi), has been approved by the Food and Drug Administration for the second-line treatment of adult patients with relapsed or […]
June 24, 2022

Roe v. Wade Overturned, Ending 50 Years of Abortion Protections Roe v. Wade Overturned, Ending 50 Years of Abortion Protections

Editor’s note: This story has been updated.  The US Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the […]
June 23, 2022

FDA Volara Ventilator Warning Upgraded to Full Recall FDA Volara Ventilator Warning Upgraded to Full Recall

The US Food and Drug Administration (FDA) has changed the warning about the Volara system to a Class I recall, the most severe level of recall, […]
June 23, 2022

Dabrafenib-Trametinib Combo Approved for Range of Solid Tumors Dabrafenib-Trametinib Combo Approved for Range of Solid Tumors

The US Food and Drug Administration has granted accelerated approval to dabrafenib (Tafinlar) plus trametinib (Mekinist) for adult and pediatric patients aged 6 years and older […]
June 23, 2022

Class I Recall for Medtronic’s HeartWare HVAD Batteries Class I Recall for Medtronic’s HeartWare HVAD Batteries

Medtronic, Inc. is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two […]
June 22, 2022

FDA Recalls SafeStar 55 Breathing System Filters FDA Recalls SafeStar 55 Breathing System Filters

The US Food and Drug Administration (FDA) issued a Class I product recall for the SafeStar 55 Breathing System Filter. The manufacturer, Germany based Draeger Inc, […]
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