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September 1, 2021

Three JAK Inhibitors Get Boxed Warnings, Modified Indications Three JAK Inhibitors Get Boxed Warnings, Modified Indications

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood […]
September 1, 2021

FDA Approves First Twice-Yearly Antipsychotic for Schizophrenia FDA Approves First Twice-Yearly Antipsychotic for Schizophrenia

The US Food and Drug Administration (FDA) has approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, Janssen Pharmaceuticals) for the […]
August 27, 2021

FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab

The US Food and Drug Administration (FDA) has approved the Vivistim System (MicroTransponder), a first-of-its kind vagus nerve stimulation (VNS) system intended to treat moderate-to-severe upper […]
August 24, 2021

FDA Okays New PAD Indication for Rivaroxaban (Xarelto) FDA Okays New PAD Indication for Rivaroxaban (Xarelto)

The US Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the direct oral anticoagulant rivaroxaban (Xarelto) to include patients […]
August 24, 2021

FDA Approves Medtronic’s Next-Gen Evolut FX TAVR System FDA Approves Medtronic’s Next-Gen Evolut FX TAVR System

The US Food and Drug Administration has approved Medtronic’s Evolut FX system for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis at all […]
August 20, 2021

FDA Warns Again About Robotic Mastectomy, Breaks New Ground FDA Warns Again About Robotic Mastectomy, Breaks New Ground

The US Food and Drug Administration (FDA) today issued a new safety communication about the use of robotically assisted mastectomy, warning patients and physicians that the […]
August 19, 2021

FDA Okays Empagliflozin for HFrEF FDA Okays Empagliflozin for HFrEF

The U.S. Food and Drug Administration approved empagliflozin (Jardiance) as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) regardless of whether patients […]
August 18, 2021

FDA Warns Clinicians to Stop Using Eco-Med Products FDA Warns Clinicians to Stop Using Eco-Med Products

The US Food and Drug Administration (FDA) is urging healthcare providers to immediately stop use of and discard all Eco-Med ultrasound gels and lotions because of […]
August 17, 2021

FDA Approves Pfizer’s Tick-borne Encephalitis Vaccine FDA Approves Pfizer’s Tick-borne Encephalitis Vaccine

The US Food and Drug Administration (FDA) has approved Pfizer’s TicoVac vaccine for the treatment of tick-borne encephalitis (TBE). The vaccine is approved outside of United […]
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