TherapeuticsMD announces FDA approval of TX-001HR: BIJUVA™ (estradiol and progesterone) capsules for the treatment of moderate to severe vasomotor symptoms due to menopause. BIJUVA is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus. BIJUVA is expected to be available…

The US Food and Drug Administration (FDA) has approved Ansh Labs' PicoAMH Elisa diagnostic test to help determine a woman's menopausal status. The PicoAMH Elisa test measures anti-Müllerian hormone (AMH), a marker of ovarian function, and is meant to be used in conjunction with other clinical assessments and laboratory findings. Data from 690 women aged 42 to 62 years showed that the PicoAMH Elisa test performed "reasonably well" at determining blood AMH levels and identifying women who had…

The first new flu drug in 20 years won approval Wednesday from the Food and Drug Administration.

The new antiviral, generically known as baloxavir marboxil but sold under the brand name Xofluza, is a single dose treatment. It is for use only in those aged 12 or more, the F.D.A. said, and should be taken only in the first two days after symptoms like fever, aches and sniffles appear.

The pill will cost $150, according to a spokeswoman for Genentech, which will sell Xofluza in this country. Genentech will offer coupons that lower the price to $30 for patients with health insurance and to about $90 for the uninsured.

Flu season has already begun, and last year’s was one of the most lethal in decades; about 80,000 Americans died of flu or its consequences, the Centers for Disease Control and Prevention said earlier this month.

The new drug is no miracle cure and it is not approved for young children, who are one of the most vulnerable groups, so the C.D.C. still strongly recommends that every American over the age of six months get a flu shot as soon as possible.

Cleveland Clinic -- Charis Eng, MD, PhD, Founding Chair of Cleveland Clinic’s Genomic Medicine Institute, Founding Director of the Center for Personalized Genetic Healthcare, and internationally recognized leader in the cancer genetics field, has received the American Cancer Society’s prestigious Medal of Honor award. The annual award recognizes individuals who have made significant contributions in basic cancer research, clinical research and cancer control. Dr. Eng was honored alongside four…

Dr. Holly L. Thacker, Dr. Anna Camille Moreno and Dr. Sabrina K. Sikka discuss the genitourinary syndrome of menopause in breast cancer survivors and the treatments available in the Cleveland Clinic Journal of Medicine.When treating the genitourinary syndrome of menopause (GSM) in women with breast cancer or at high risk of breast cancer, clinicians must balance the higher cancer risks associated with hormonal treatments against the severity of GSM symptoms, which can be exacerbated by breast…

The US Food and Drug Administration approved the use of a human papillomavirus vaccine called Gardasil 9 for men and women between the ages of 27 and 45. The FDA previously approved the HPV vaccine for people age 9 to 26. Most HPV infections go away on their own, but some remain and can cause cervix, vagina and vulva cancer in women; penis cancer in men; and genital warts, anal cancer and head and neck cancers in both sexes. There are 150 viruses that make up HPV, but most are rare. Gardasil…

The North American Menopause Society's September issue of Menopause e-Consult features expert commentary from Dr. Heather Hirsch on midlife-related clinical issues. Dr. Hirsch is a graduate of the Cleveland Clinic Specialized Women's Health fellowship program. ► Question: After she recently screened positive for BRCA2 mutation, a 42-year-old woman in my practice underwent risk-reducing salpingo-oophorectomy (RRSO). Now that she is postmenopausal, she suffers from significant night sweats, poor…

The FDA cautions against energy-based procedures In July 2018, the FDA released a statement of concern reiterating the need for research and randomized clinical trials before energy-based device treatments can be widely accepted, and that they are currently cleared only for general gynecologic indications and not for disorders and symptoms related to menopause, urinary incontinence, or sexual function. The FDA stated that “we have not cleared or approved for marketing any energy-based devices…

From the CDC and the ACIPThe CDC and the CDC’s Advisory Committee on Immunization Practices (ACIP) recently released updated recommendations regarding the influenza vaccine for the 2018-19 “flu season.” This report updates the 2017–18 ACIP recommendations. The ACIP continues to recommend that all persons 6 months and older to receive routine annual influenza vaccination with a licensed, recommended, and age-appropriate vaccine, unless they have specific contraindications. Two of the three viral…

The Ohio Department of Medicaid is changing the way it pays for prescription drugs, giving the boot to all pharmacy middlemen because they are using "spread pricing," a practice that has cost taxpayers hundreds of millions. Medicaid officials directed the state's five managed care plans Tuesday to terminate contracts with pharmacy benefit managers using the secretive pricing method and move to a more transparent pass-through pricing model effective Jan. 1. "It will provide volumes of…

The Food and Drug Administration has approved elagolix (Orilissa) for oral treatment of moderate to severe pain associated with endometriosis, announced AbbVie and Neurocrine Biosciences; this approval makes it the first such treatment in more than a decade. Elagolix is a gonadotropin-releasing hormone (GnRH) antagonist and the first and only one developed specifically for managing this kind of pain. The approval is based on two 6-month, randomized, double-blind, placebo-controlled phase 3…

The US Food and Drug Administration (FDA) is cracking down on manufacturers marketing the use of laser or other energy-based devices for "vaginal rejuvenation" which manufacturers claim will treat conditions and symptoms related to menopause, urinary incontinence, or sexual function. "The procedures use lasers and other energy-based devices [such as radiofrequency] to destroy or reshape vaginal tissue. These products have serious risks and don't have adequate evidence to support their use for…

Indiana patient describes her positive experiences using the Cleveland Clinic Express Care Online app for virtual appointments with Dr. Holly L. Thacker. Patient Mary Margaret Lavelle scheduled an online medical appointment and instructions for the virtual appointment were emailed to her. “It was quick and easy. I just downloaded the Cleveland Clinic Express Care Online app and logged in shortly before the appointment. After a short wait in the virtual waiting room, there was Dr. Thacker…

Many women recognize subtle signs that their period is about to start. An uptick in chocolate cravings, unexplained crankiness and fatigue are common symptoms of premenstrual syndrome (PMS) that typically come and go relatively quickly. But for others, these symptoms are anything but subtle. A small percentage of women (3%-9%) have premenstrual dysphoric disorder (PMDD), a medical condition that causes intense physical and emotional symptoms beginning up to two weeks before menstruation…

Pharmacy benefit managers, or PBMs, are supposed to help control costs for payers and lower out-of-pocket costs for plan members. But as a team of investigative journalists with the Columbus Dispatch are revealing, some pharmacy benefit managers are skimming hundreds of millions of dollars in Ohio alone, boosting drug costs for everyone. Pharmacy benefit managers market themselves as keen negotiators able to squeeze pharmaceutical manufacturers for better deals that save money for insurers,…

The first drug developed specifically to reduce excessive sweating, a common condition that can cause people anxiety and affect their social lives, has been approved. The Food and Drug Administration approved Qbrexza for excessive underarm sweating and will be available in October 2018. The drug is inside a cloth wiped over the skin daily to block sweat glands from activating.

The American Cancer Society, responding to a rise in colorectal cancer rates among younger people, is now recommending that adults undergo screening for the disease beginning at age 45 rather than 50. The organization, which announced the change in its guidelines Wednesday, said extensive analysis showed that lowering the starting age for screening would save lives. The recommendations apply to adults who are at average risk of the disease; this includes most people in the United States.

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXY™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

FDA News Release The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. “Aimovig provides patients with a novel option for reducing the number of days with…