BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) announces that Health Canada has approved Tibella® (tibolone), indicated for the short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause. Tibella® is a prescription hormone replacement therapy (“HRT”) consisting of tibolone. Tibella® is different from other HRTs, as it does not contain actual hormones. Instead, the body breaks down tibolone to make three…

By Marie Fidela Paraiso, MD As President of the American Association of Gynecologic Laparoscopists (AAGL), I have been fielding calls from colleagues, patients, media and industry about the recent announcement from the U.S. Food and Drug Association, which recalled transvaginal mesh used for the treatment of pelvic organ prolapse (POP). An important distinction There’s an important distinction to make here: the FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh for…

The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies failed to provide reasonable assurance that the products are safe and effective. The three vaginal mesh devices available in the United States are Boston Scientific's Uphold LITE and Xenform, and Coloplast's Restorelle DirectFix Anterior. The companies have 10 days to submit their plan to withdraw these…

Speaking of Women's Health has been named one of Healthline's best women's health blogs of 2019. Each year, Healthline looks for blogs that are inspiring, educating, and empowering women to lead their best lives — in more ways than one. This year Speaking of Women's Health is one of fourteen blogs to be awarded the title. This is the third year in a row that Speaking of Women's Health has been selected by Healthline as Best Women's Health Blog.

The US Food and Drug Administration (FDA) has approved the humanized monoclonal antibody romosozumab (Evenity, Amgen) for treatment of osteoporosis in postmenopausal women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. Earlier this year, the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of romosozumab for this indication, as reportedby Medscape…

Women with dense breasts who get mammograms must be told of their higher risk for breast cancer under new rules proposed Wednesday by the U.S. Food and Drug Administration. The FDA would also tighten its regulation of mammogram facilities, giving the agency the power to notify patients if problems are found at a center so that repeat mammograms can be done at another certified center. "The steps we are announcing today are intended to modernize breast cancer screening and help empower…

The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. "Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks…

Up to one-third of adults with major depression battle symptoms such as persistent feelings of sadness, trouble sleeping, fatigue and suicidal thoughts that don’t respond to treatment. Yet there’s been very little new on the market since Prozac® (fluoxetine) revolutionized the treatment of depression in 1988. Until now. The Food and Drug Administration approved the nasal spray esketamine as the first new type of treatment for depression in over three decades. Here’s what you need to…

Children who receive the measles, mumps and rubella (MMR) vaccine are not at increased risk for autism, and that includes children who are sometimes considered to be in "high risk" groups for the neurodevelopmental disorder, a massive new study finds.The new study, published March 4 in the journal Annals of Internal Medicine, is one of the largest studies of its kind to date. In it, researchers looked at the records of more than 657,000 children born in Denmark between 1999 and 2010, including…

The FDA reports additional cases of cancer linked to breast implants. Anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma is a known risk from breast implants. In 2011, the FDA was the first public health agency in the world to communicate about the risks of BIA-ALCL, warning women that the available information at the time indicated that there is a risk for women with breast implants for developing this disease. The FDA hopes that this information prompts providers and…

Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson proposed a rule to lower prescription drug prices and out-of-pocket costs by encouraging manufacturers to pass discounts directly on to patients and bringing new transparency to prescription drug markets. “Every day, Americans—particularly our seniors—pay more than they need to for their prescription drugs because of a hidden system of kickbacks to middlemen. President Trump is proposing to end this…

Myriad Genetics has announced study findings that showed patients with major depression who received treatment guided by GeneSight®, a pharmacogenomic test, experienced a higher rate of remission and response, as well as greater improvement in symptoms than those who received treatment-as-usual. This is a land-breaking study showing how after 30 or 40 years, improvement in patient outcomes in depression by marrying-up the right medication to the right patient using their genetics. Patients…

Migraine is characterized by attacks of throbbing, often unilateral headache that are exacerbated by physical activity and associated with photophobia, phonophobia, nausea, and vomiting. About one third of patients have migraine with an aura and three quarters experience a premonitory phase prior to the onset of headache. Diagnoses of migraine can be refined based on the frequency of monthly migraine days (MMDs) and monthly headache days (MHDs); patients with fewer than 15 MMDs or MHDs have…

Potential New Treatment Option for the Treatment of Postmenopausal Women With Osteoporosis at High Risk for FractureAmgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITY™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the…

Every few years a new superfood emerges, promising health benefits beyond your wildest dreams. Right now, kakadu plums are having a moment. In fact, with the highest levels of vitamin C of any fruit — in the entire world — and more antioxidants than the blueberry, kakadu plums are the stuff superfood lore is made of. So what are kakadu plums, and what can they do for you? Kakadu plums are a small light green fruit native to Australia, that’s also called the billygoat plum, bush plum, or salty…

The mosquito-borne virus that causes Rift Valley fever may severely injure human fetuses if contracted by mothers during pregnancy, according to new research. Rift Valley fever primarily occurs in livestock in sub-Saharan Africa, where outbreaks cause 90 to 100 percent of pregnant cows in a herd to miscarry or deliver stillborn calves, often a significant economic loss. But hundreds of cases also occur in humans each year, causing flu-like symptoms and severe liver problems. The outbreaks…

Stores across the United States and Canada are pulling some Kotex Tampons off their shelves after the manufacturer issued a recall due to a "quality-related defect" that saw the tampon unravel and leave pieces inside consumers' bodies. The recall was issued by Kimberly-Clark, after several customers reported the tampons unraveled or come apart during removal. Others reported needing medical attention to remove tampon pieces that remained in their body while some people reported infection,…

Two doses of elagolix are now FDA approved for treatment of pelvic pain caused by endometriosis. These two doses allow clinicians to opt for gentle (150 mg once daily) or strong (200 mg twice daily) suppression of estradiol to manage pelvic pain, as well as the associated effects of low estradiol levels. Endometriosis is the presence of tissue resembling endometrial glands and stroma outside of the uterine cavity. Women with endometriosis often present for medical care with at least 1 of 3…

The North American Menopause Society's November 2018 issue of Menopause e-Consult features expert commentary by Speaking of Women's Health Executive Director Dr. Holly L. Thacker on midlife-related clinical issues.Case A 44-year-old woman presents to the clinic and reports that she has been having severe hot flashes and a diminished sex drive since undergoing endometrial ablation at age 36 for abnormal uterine bleeding. The hot flashes interfere with her daytime chores and cause nighttime…

TherapeuticsMD announces FDA approval of ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system) for birth control. ANNOVERA is the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible.The ANNOVERA contraceptive vaginal system is a small, soft flexible ring that prevents ovulation for an entire year (13 cycles) and can be inserted and removed by a woman at her discretion in repeated four-week cycles (remaining in place…