Columbus, OH

Inspire Medical Systems, a medical technology company focused on the development and commercialization of minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the FDA approval of the Inspire V therapy system which includes the next generation neurostimulator and the associated Bluetooth patient remote and physician programmer. Inspire...

FDA Approves 'Mask-Free' Sleep Apnea Treatment Device

This marks the first approval of a systemic therapy for patients with grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation. The FDA approved vorasidenib (Voranigo) for the treatment of adult and pediatric patients aged 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation who have undergoing biopsy, subtotal resection, or gross total resection.

FDA Approves Vorasidenib to Treat Grade 2 Astrocytoma, Oligodendroglioma With IDH1, IDH2 Mutations

Servier has expanded its IDH drug armamentarium with the FDA approval for an IDH1/2 dual inhibitor. The approval represents the first major treatment advance in low-grade brain cancer in more than two decades. The new FDA approval is for Servier’s Voranigo, or vorasidenib, for adult and children ages 12 and...

Servier snags FDA approval for Voranigo, the first targeted therapy for a common type of brain tumor

Inspire Medical Systems received Food and Drug Administration approval for its Inspire V obstructive sleep apnea (OSA) neurostimulator therapy, the company said Friday. Inspire plans to start a soft launch of the device late in 2024 and move into a full launch in 2025. The company disclosed the approval days...

Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy

Strokes are caused by limited blood flow to the brain. Described as a cardiovascular disease, strokes result from a clogged or blocked blood vessel that leads to a lack of oxygen. Around 800,000 individuals have a stroke each year in the United States. The most common type of stroke is referred to as ischemic, which occurs when blood is occluded from a clot or narrow blood vessel. If the brain has low blood exposure, it limits the oxygen and nutrients the brain needs. As a result, brain cells begin to die, and a stroke occurs.

Strokes Have a Lasting Effect on Immune Cells

New York City, NY

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Cheryl E Preston

Yesterday was the third time this year that an ad stating Chelsea Clinton lives in a beautiful Virginia home popped up on my laptop. My computer did not warn me this was a dangerous site, so this time, I clicked on the link.

Chelsea Clinton is rumored to be living in Virginia but probably still in NYC

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The Lens

This year’s area of low oxygen in the Gulf of Mexico is larger than average, the National Oceanic and Atmospheric Administration (NOAA) announced on Thursday. The “dead zone” is approximately 6,705 square miles , as measured last week. Within NOAA’s 38 years of measuring the dead zone, this year’s assessment marks the 12th-largest area of low to no oxygen, which can kill fish and marine life.

Gulf ‘dead zone’ larger than average, larger than expected for 2024, scientists announce

Contributors represent independent, third-party users who have joined our contributor program and self-verified their accounts. They have also demonstrated their experience writing hard news for other outlets. Contributors are expected, like all users, to adhere to our Community Standards.

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The Current GA

Since 2020, the condition known as long COVID-19 has become a widespread disability affecting the health and quality of life of millions of people across the globe and costing economies billions of dollars in reduced productivity of employees and an overall drop in the work force .

Expert: Long COVID puzzle pieces are falling into place – picture is unsettling

SPEARHEAD-1 Efficacy was evaluated in cohort 1 of the SPEARHEAD-1 study (ClinicalTrials.gov identifier NCT04044768), a multicenter, single-arm, open-label clinical trial that enrolled HLA-A*02:01-03 and 06 allele–positive patients with inoperable or metastatic synovial sarcoma who had received prior systemic therapy with either doxorubicin and/or ifosfamide and whose tumor expressed the MAGE-A4 tumor antigen. Patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide.

FDA Grants Accelerated Approval to T-Cell Therapy for Unresectable or Metastatic Synovial Sarcoma

Octapharma USA, Inc. has announced the expanded approval of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the FDA. As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate).

FDA Approves Additional Indication for Fibryga® for Fibrinogen Supplementation in Bleeding Patients with Acquired Fibrinogen Deficiency

Chicago, IL

Foodie in Chicago

Shortly before 3 AM, people in the Chicago area may have felt their houses shake as a 3.4-magnitude earthquake occurred about 60 miles west of the city. (CHICAGO) The United States Geological Survey (USGS) reported a 3.4-magnitude earthquake around Somonauk, IL. Somonauk is in DeKalb and LaSalle Counties, 64 miles west of Chicago.

Did You Feel the Earthquake?

The following is a summary of “Associations of Kidney Functional Magnetic Resonance Imaging Biomarkers with Markers of Inflammation in Individuals with CKD,” published in the May 2024 issue of Nephrology by Trujillo et al. More fibrosis and less oxygenation may increase overall inflammation, but not much data is...

Link Between Inflammatory Markers and Kidney fMRI in Patients with CKD

The Food and Drug Administration (FDA) has approved Servier Pharmaceuticals’ Voranigo for treating two types of low-grade gliomas. This anticipated blockbuster drug originates from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology division. Vorasidenib (Voranigo, formerly AG-881) is a first-in-class treatment for patients with IDH-mutant gliomas, marking Servier’s sixth approval for cancers with IDH mutations.

Servier’s Major Acquisition Pays Off: FDA Approves First-In-Class Treatment for Two Types of Rare Brain Cancer

The FDA has granted accelerated approval to Adaptimmune’s Tecelra, a T cell therapy for the treatment of synovial sarcoma when other lines of treatment do not work. Adaptimmune has announced the FDA approval of Tecelra, making it the first engineered cell therapy to receive approval for a solid tumor indication and the first T cell receptor (TCR) therapy to enter the US market. With this approval, Tecelra also becomes the first new treatment option in more than a decade for people with synovial sarcoma, a rare soft tissue cancer that most commonly impacts young adults.

Adaptimmune’s Tecelra becomes the first FDA-approved cell therapy for a solid tumor

Orange County, CA

Corcoran, CA

NewSantaAna

CORCORAN – California Department of Corrections and Rehabilitation (CDCR) officials are investigating the July 28, 2024, death of an incarcerated person at California Substance Abuse Treatment Facility as a homicide.

Pimp arrested in Orange County killed by an inmate at a state prison

Federal drug safety regulators have received nearly 300,000 adverse event reports involving health problems with Ozempic, Wegovy, Mounjaro and similar drugs from the same class of medications, highlighting the growing concerns about side effects associated with the widely used diabetes and weight loss treatments. In a report published last week...

FDA Database Reveals High Number of Severe Adverse Events Involving Problem from Ozempic, Similar GLP1 Drugs

Patients with concomitant HIV and pulmonary hypertension experience worse outcomes versus patients with HIV alone, including higher in-hospital mortality. Patients with concomitant HIV and pulmonary hypertension (PH) experience worse outcomes compared with patients with HIV alone, including higher in-hospital mortality, longer length of stay, and increased healthcare costs, according to results published in the International Journal of Cardiology.

Analyzing Hospital Outcomes for Patients With HIV & Pulmonary Hypertension

Ann Arbor, MI

MONDAY, Aug. 5, 2024 (HealthDay News) — Direct oral anticoagulant (DOAC) prescribing oversight for off-label prescribing is beneficial while patients are prescribed DOAC, according to a study published online July 30 in Thrombosis and Haemostasis. Grace C. Herron, from the Frankel Cardiovascular Center at the University of Michigan in...

Oversight of DOAC Prescribing Beneficial for A-Fib, VTE Patients

Various factors can increase the risk of developing migraine, including genetics, hormonal changes, and lifestyle choices like smoking. Migraine is a neurological condition involving intense, debilitating headaches often accompanied by symptoms like increased sensitivity to light and sound, nausea, and vomiting. This article explores various migraine risk factors and discusses...

What Are Risk Factors for Migraine?

The U.S. Food and Drug Administration has issued a new warning about a popular medication used for weight loss. The FDA says it has received reports of people overdosing on compounded semaglutide, giving themselves as much as 20 times more than the intended dose of the medication. The incidents, some...

Some people are overdosing on semaglutide, FDA warns

NewsBreak

Cloughesy’s Insights on the FDA Approval of Vorasidenib in IDH-Mutant Gliomas

Timothy F. Cloughesy, MD, discusses the impact and significance of the FDA’s approval of vorasidenib, a first-in-class option for the treatment of patients with IDH-mutant gliomas....

Cloughesy’s Insights on the FDA Approval of Vorasidenib in IDH-Mutant Gliomas

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