Study Results

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Healthy woman at beach

NEXTSTELLIS® ORAL CONTRACEPTIVE NOW AVAILABLE IN THE UNITED STATES

21 June 2021, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited
(ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very
pleased to announce the US commercial launch of NEXTSTELLIS® (3 mg drospirenone
and 14.2 mg estetrol (E4) tablets), a new oral contraceptive with a novel estrogen having
a unique mechanism of action.

hypoactive sexual desire disorder

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women…

Woman Diagnosed with Bacterial Vaginosis

Daré Bioscience Announces Positive Topline Results From DARE-BVFREE, a Phase 3 Trial of DARE-BV1 in Patients Diagnosed with Bacterial Vaginosis

SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in 307 women diagnosed with bacterial vaginosis, a serious condition estimated to affect approximately 21 million women in the United States….

woman with uterine fibroids

Myovant Sciences and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE®. MYFEMBREE® gives women with uterine fibroids a non-invasive treatment through one pill, once-a-day and is expected to become available starting in June 2021.

Myovant Sciences and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE®. MYFEMBREE® gives women with uterine fibroids a non-invasive treatment through a once-a-day pill and is expected to become available starting in June 2021.

FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women

NORTH CHICAGO, Ill.May 29, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months.

Therapy in Women with Endometriosis and from Ovulation Inhibition Study

FDA APPROVES AGILE THERAPEUTICS, INC.’S TWIRLA® (LEVONORGESTREL AND ETHINYL ESTRADIOL) TRANSDERMAL SYSTEM – A NEW WEEKLY CONTRACEPTIVE PATCH DELIVERING A 30 MCG DAILY DOSE OF ESTROGEN AND 120 MCG DAILY DOSE OF PROGESTIN

PRINCETON, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Twirla® (levonorgestrel and ethinyl estradiol) transdermal system…

Myovant Sciences Combination Therapy in Women with Uterine Fibroids

U.S. FDA Approves Evofem Biosciences’ Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy

Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing

SAN DIEGOMay 22, 2020 /PRNewswire/ — Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception…

Woman with Endometriosis

Myovant Sciences Announces Positive Results from Second Phase 3 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis

BASEL, Switzerland, June 23, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced top-line results from SPIRIT 1, the second of two Phase 3 studies of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis…

Healthy woman

SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections

SCYNEXIS, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years.

Evofem Biosciences, Inc. clinical trial of Amphora

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

Basel, 21 April 2020 – Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into precancerous lesions and, if left untreated, these lesions can progress to cervical cancer.

Cranberry in bowl

FDA Announces Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections

The U.S. Food and Drug Administration announced today in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women…

Post-Menopausal Woman

Non-Hormonal Agent Improves Sleep, Mood in Post-Menopausal Women: Presented at NAMS

CHICAGO — October 2, 2020 — NT-814, a non-hormonal dual neurokinin (NK) 1 and 3 receptor antagonist, significantly improved sleep, mood, and quality of life in post-menopausal women, according to a study presented at the 2020 Virtual Meeting of the North American Menopause Society (NAMS).

Mycovia Pharmaceuticals Announces Positive Topline Results from Phase 3 VIOLET Studies of Oteseconazole in Patients with Recurrent Vulvovaginal Candidiasis

Durham, N.C. – December 9, 2020 – Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced positive topline results from its two pivotal Phase 3 VIOLET clinical trials for oteseconazole, its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC).