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September 17, 2021

EMA Endorses Injectable Malaria Drug Artesunate EMA Endorses Injectable Malaria Drug Artesunate

The European Medicines Agency’s human medicines committee has recommended approval for an intravenous treatment for severe malaria. The Committee for Medical Products for Human Use (CHMP) […]
September 17, 2021

Flurry of Cancer Drug Endorsements From EU Panel Flurry of Cancer Drug Endorsements From EU Panel

Three new cancer drugs have been recommended for approval in Europe, as well as new indications for two already marketed immunotherapies. The positive opinions were issued […]
September 16, 2021

As Opioid Deaths Climb, Human Trials Begin for Vaccine As Opioid Deaths Climb, Human Trials Begin for Vaccine

Opioid-related drug overdose deaths in the United States exploded to an estimated record high of 69,031 people in 2020, topping the 49,860 deaths logged in 2019, […]
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 […]
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