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LIV Golf Postpones New Orleans Tournament Amid Funding Concerns

LIV Golf Postpones New Orleans Tournament Amid Funding Concerns

LIV Golf Postpones New Orleans Tournament Amid Funding Concerns
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FDA Approves New Quadruplet Regimen for Transplant-Ineligible Multiple Myeloma Patients

FDA Approves New Quadruplet Regimen for Transplant-Ineligible Multiple Myeloma Patients

The U.S. Food and Drug Administration (FDA) has approved a new treatment regimen for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The regimen, known as DVRd, combines DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone. This approval is based on the Phase 3 CEPHEUS study, which demonstrated a significant improvement in minimal residual disease (MRD)-negativity rates compared to the previous standard regimen. The study showed that DVRd achieved a 52.3% MRD-negativity rate at a median follow-up of 22 months, compared to 34.8% with the previous regimen. This marks the third indication for DARZALEX FASPRO® in transplant-ineligible patients, reinforcing its role in the treatment landscape for multiple myeloma.
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Intellia Therapeutics Begins FDA Submission for CRISPR-Based Hereditary Angioedema Treatment

Intellia Therapeutics Begins FDA Submission for CRISPR-Based Hereditary Angioedema Treatment

Intellia Therapeutics Begins FDA Submission for CRISPR-Based Hereditary Angioedema Treatment
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Study Links Common Pregnancy Medications to Increased Autism Risk in U.S. Children

Study Links Common Pregnancy Medications to Increased Autism Risk in U.S. Children

A study conducted by the University of Nebraska Medical Center has found a significant link between the use of certain medications during pregnancy and an increased risk of autism spectrum disorder (ASD) in children. The research, published in Molecular Psychiatry, analyzed 6.14 million maternal-child health records from the Epic Cosmos database, covering nearly one-third of U.S. births from 2014 to 2023. The study identified that drugs disrupting cholesterol production pathways, including some antidepressants and statins, were associated with higher ASD rates. Pregnant individuals prescribed at least one of these medications had a 1.47 times higher likelihood of having a child with ASD, with the risk increasing with the number of medications used.
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Kentucky Wildcats News: Head Coach Rajon Rondo?

Kentucky Wildcats News: Head Coach Rajon Rondo?

Former Kentucky Wildcat and two-time NBA champion Rajon Rondo is reportedly in the running to be a NBA head coach. According to Marc Stein, the New Orleans Pelicans are largely considering Rondo for their HC position. He spent the 2017-2018 season as the starting point guard, averaging eight points and as many assists in 65 […]
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Veradermics Announces Conference Call to Discuss Phase 2/3 Study Results for Hair Loss Treatment

Veradermics Announces Conference Call to Discuss Phase 2/3 Study Results for Hair Loss Treatment

Veradermics Announces Conference Call to Discuss Phase 2/3 Study Results for Hair Loss Treatment
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FDA Approves AstraZeneca's Saphnelo Autoinjector for Lupus Self-Use in the US

FDA Approves AstraZeneca's Saphnelo Autoinjector for Lupus Self-Use in the US

AstraZeneca's Saphnelo (anifrolumab) has received approval from the US Food and Drug Administration (FDA) for self-administration as a once-weekly autoinjector, known as the Saphnelo Pen, for adult patients with systemic lupus erythematosus (SLE). This approval is based on the Phase III TULIP-SC trial results, which demonstrated a significant reduction in disease activity compared to placebo in patients with moderate to severe SLE. The safety profile of the autoinjector is consistent with the intravenous infusion of Saphnelo. The approval is seen as a significant advancement in making the medication more accessible and convenient for patients. SLE is a serious autoimmune condition affecting millions worldwide, and the new administration option offers more flexibility in treatment.
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GE HealthCare Initiates Phase 2/3 Trial for Manganese-Based MRI Contrast Agent with FDA Fast Track Designation

GE HealthCare Initiates Phase 2/3 Trial for Manganese-Based MRI Contrast Agent with FDA Fast Track Designation

GE HealthCare has announced the dosing of the first patient in the Phase 2/3 LUMINA clinical trial for its manganese-based MRI contrast agent, mangaciclanol, at the Mayo Clinic in Rochester, Minnesota. This investigational agent, which has received Fast Track designation from the U.S. Food and Drug Administration (FDA), is being developed as a potential alternative to gadolinium-based MRI contrast agents. Mangaciclanol aims to enhance the visualization of abnormal structures during MRI procedures, offering comparable diagnostic capabilities to existing gadolinium-based agents. Unlike gadolinium, manganese is a naturally occurring element in the body, which may reduce concerns about retention and environmental impact.
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Fitzpatrick Brothers Lead Zurich Classic with Record-Setting Performance

Fitzpatrick Brothers Lead Zurich Classic with Record-Setting Performance

Fitzpatrick Brothers Lead Zurich Classic with Record-Setting Performance
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Potential Lifesaving Pill for Snakebites in Development by Bay Area Company

Potential Lifesaving Pill for Snakebites in Development by Bay Area Company

Ophirex, a Bay Area-based public benefit corporation, is developing a pill called Varespladib that could potentially save lives by neutralizing snake venom. The pill is designed to be taken immediately after a snakebite, providing critical time for victims to reach medical facilities for further treatment. Varespladib targets a key toxin present in 95% of snake species, including several common in the United States. The company is working towards FDA approval for human and canine use, with plans to make the pill accessible to hikers and emergency personnel. This development comes amid a reported increase in snakebite incidents, highlighting the need for effective pre-hospital treatments.
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Ophirex Develops Potential Lifesaving Anti-Venom Pill Amid Rising Snakebite Fatalities

Ophirex Develops Potential Lifesaving Anti-Venom Pill Amid Rising Snakebite Fatalities

Ophirex, a Bay Area-based public benefit corporation, is advancing the development of an anti-venom pill named Varespladib, which could significantly improve survival rates for snakebite victims. This development comes in response to a notable increase in snakebite fatalities in California, where three deaths have been reported in just two months. The Centers for Disease Control and Prevention typically reports an average of five snakebite deaths annually across the United States. Varespladib works by neutralizing a key toxin present in 95% of snake species and is intended to be used alongside hospital-administered anti-venom treatments. The pill is particularly effective against common North American snakes, including several rattlesnake species and the Copperhead. Ophirex aims to secure FDA approval for human and canine use by late next year, with the goal of making the treatment accessible to backpackers and emergency personnel.
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CGBIO Achieves FDA Clearance for Customized Titanium Implants in U.S. Market

CGBIO Achieves FDA Clearance for Customized Titanium Implants in U.S. Market

CGBIO Achieves FDA Clearance for Customized Titanium Implants in U.S. Market