The FDA has cleared a noninvasive device to relieve acute migraine pain. Nerivio Migra is a "first-in-category product," according to Theranica, the company that makes it. It is worn on the upper arm and uses smartphone-controlled electronic pulses to relieve migraine pain. The device is for the acute treatment of migraine with or without aura in adults who don’t have chronic migraine. The FDA approved the device on the basis of results of a randomized, double-blind, placebo-controlled…

The US Food and Drug Administration approved a drug to return sexual desire to some women with low libido, the agency said Friday. The drug, bremelanotide, sold under the brand name Vyleesi by AMAG Pharmaceuticals, is an injection to be taken before sex. It's intended to treat women who are premenopausal and have hypoactive sexual desire disorder, where a lack of interest in sex may cause significant distress in a woman's life. It will be available in September, and the company has not yet…

The US Food and Drug Administration (FDA) has approved Slynd (drospirenone) for use as an oral contraceptive pill. The pill contains drospirenone 4 mg and comes in sets of 24 active pills along with 4 inactive tablets.The New Drug Application (NDA) for drospirenone was submitted to the FDA by Exeltis USA, Inc, which announced the approval of this progestin-only contraceptive tablet."Slynd may be an excellent choice for women who need or want safe and effective oral contraception without the…

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,…