U.S. health regulators on Monday approved a first-of-its-kind blood test for colon cancer, offering a new way of screening for a leading cause of cancer deaths.Test manufacturer Guardant said the Food and Drug Administration approved its Shield test for screening in adults 45 and older who have an average risk of colon cancer. The test isn’t a replacement for colonoscopies, but provides a noninvasive approach to screening.Doctors can already order Shield for patients as a laboratory test with…

The Food and Drug Administration (FDA) expanded the approvals of two tests that detect cancer-causing types of human papillomavirus (HPV) in the cervix. Both tests are used as part of screening for cervical cancer.Under these expanded approvals, people can now be offered the option to collect a vaginal sample themselves for HPV testing if they cannot have or do not want a pelvic exam. However, the collection, which involves a swab or brush, must be done in a health care setting, such as primary…

PET scans showing brain estrogen receptor (ER) density in a premenopausal (left) and a postmenopausal (right) woman. The color scale reflects brain ER density, with brighter colors indicating more receptors. The postmenopause scan looks ‘yellower’ and overall brighter, indicating that the woman’s brain has significantly more estrogen receptors than the premenopausal brain. Credit: Mosconi lab.The transition to menopause is marked by a progressively higher density of estrogen receptors (ER) on…

By Dr. Alexa FiffickIt is well known that midlife women encounter significant health changes, particularly those associated with the menopause transition. But did you know that not having policies to support those health changes may be hurting your company's profits and costing American businesses billions?In a 2023 study by the Mayo Clinic, 13.4% of women reported one or more adverse workplace outcomes – such as absenteeism or reduced productivity – due to symptoms associated with menopause…

The U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation…

The menopause experts that represent Speaking of Women's Health and work in the Cleveland Clinic Center for Specialized Women's Health have always individualized assessment and care for their patients. Their message to patients is there is no age limit for hormone therapy and every woman deserves treatment no matter their age!New study suggests the benefits and risks of women aged older than 65 years taking hormone therapy differ greatly depending on type, route, and dose prescribed.After the…

Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo. In this study, elinzanetant successfully met the primary endpoint demonstrating statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 12 compared to placebo. The long-term safety profile observed over 52 weeks in the…

New research suggests that taking calcium and vitamin D supplements together may be both beneficial and risky for postmenopausal women.The study, published in the Annals of Internal Medicine, found that while women who took both supplements at the same time decreased their risk of dying from cancer, they also increased their chances of death due to cardiovascular disease.1According to Holly Thacker, MD, an internist at Cleveland Clinic who specializes in menopause and women’s health conditions,…

One year after the Cleveland Clinic announced a clinical trial of the psychedelic drug LSD in treatment of anxiety disorders, it’s preparing for a new study on treating depression with psilocybin, the psychoactive ingredient in so-called “magic” mushrooms.More than 50 sites have joined in the trial to research the drug’s impact on patients diagnosed with depression that hasn’t been resolved by other treatments, according to a news release from the clinic.Patients are expected to receive…

The U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for…

New study suggests effectiveness of hormone therapy used alone or in conjunction with antidepressants to manage depressive symptoms during perimenopause and the early postmenopause years.

Women are often educated on the uncomfortable symptoms of menstruation, but being informed on the many facets of menopause often falls through the cracks.At 53, Rida Rafiq’s journey through menopause was complex, marred by a misdiagnosis of severe acid reflux. She began suffering from episodes of burning sensations that spread from her abdomen to her neck and arms, accompanied by weight loss, anxiety, and depression. Despite numerous medical interventions, including endoscopies and emergency…

AbstractBackground: Hair follicle stem cells (HFSCs) typically remain quiescent and are activated only during the transition from telogen to anagen to ensure that the hair follicle enters a new cycle. The metabolic behavior of stem cells in tissues is regulated by macroautophagy/autophagy, and changes in HFSC metabolism directly affect their activation and maintenance. However, the role of autophagy in the regulation of HFSC metabolism and function remains unclear. Autophagy is your body’s…

OASIS 1 and 2 pivotal studies evaluating investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) compared to placebo in postmenopausal womenBoth studies also showed superiority over placebo for all key secondary endpoints with a statistically significant reduction in frequency of VMS at week 1, as well as improvement of sleep disturbances and menopause-related…

Positive findings from the KEYNOTE-A18 trial support the approval of pembrolizumab, radiotherapy, and concurrent chemotherapy in patients with high-risk locally advanced cervical cancer.

Germline Testing in Patients With Breast Cancer: ASCO–Society of Surgical Oncology GuidelineAn expert panel has developed new guideline recommendations for germline testing in patients with breast cancer.Recommendations:All patients newly diagnosed with breast cancer with stage I-III or de novo stage IV/metastatic disease who are 65 years or younger at diagnosis should be offered BRCA1/2 testing.All patients newly diagnosed with breast cancer with stage I-III or de novo stage IV/metastatic…

The U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol) for use, in addition to a reduced calorie diet and increased physical activity. Tirzepatide, the active ingredient in Zepbound, is…

Menopause symptoms can be particularly frustrating. They’re different for every person, and it’s unclear why some of the most common symptoms, such as hot flashes, happen in some women but not others. The consumption of soy, such as tofu or soybeans, or in the form of supplements, in place of hormone therapy is one option — but research shows the approach may not be as helpful as the hype proclaims. Scientists have been exploring soy for menopause symptoms for decades, and most of the…

The U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA…

23andMe Holding Co. has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report*. The clearance allows 23andMe to report an additional 41 variants in the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. 23andMe received the first FDA authorization for a direct-to-consumer genetic test for cancer risk in 2018 to report 3 variants in the…