Pharma

SCYNEXIS Receives FDA Approval for BREXAFEMME, the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections

Biotech company SCYNEXIS has announced FDA (U.S. Food and Drug Administration) approval of BREXAFEMME (ibrexafungerp tablets) for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME is the first approved drug in a novel antifungal class in more than 20 years and was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated…

Myovant and Pfizer Receive FDA Approval for MYFEMBREE, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids

An estimated 5 million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated 3 million women are inadequately treated by current medical therapy and require further treatment. Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual’s genetic…

Dr. Stephen Palmer Joins the Celmatix Executive Team to Lead the Company’s Drug Discovery and Development Efforts in Ovarian Health as Chief Scientific Officer

Women’s Health Biotech Celmatix focused uniquely on ovarian biology has announced the appointment of Dr. Stephen Palmer as Chief Scientific Officer. Dr. Palmer had previously joined the company’s Scientific Advisory Board earlier this year, on the heels of rapid progress with Celmatix’s lead AMHR2 agonist program and the out-licensing of PCOS targets from its multi-omics ovarian health platform. Dr. Palmer is a…

Biovaxys Adds Charles J. Dunton, MD as Scientific Advisor to Support the Company’s Ovarian Cancer Vaccine Clinical Program and Papilocare Marketing

BioVaxys has announced that Charles J. Dunton, MD has joined BioVaxys as an Advisor to help provide additional scientific support for BVX-0918A, the Company’s ovarian cancer vaccine candidate, and its planned marketing and sale of Papilocare in the United States. Dr. Dunton, a top global opinion leader, is a gynecologist/oncologist in Indiana. He received his medical degree from Jefferson Medical College and has been in…

Evofem Receives Fast Track Designation for EVO100 for Prevention of Gonorrhea in Women

Evofem today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EVO100 for the prevention of urogenital gonorrhea in women. Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs. According to a new report published by the Centers for Disease…

Women’s Reproductive Health Pharma Company ObsEva Appoints Clive Bertram as Chief Commercial Officer

ObsEva, a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the appointment of Clive Bertram as Chief Commercial Officer and member of ObsEva’s Executive Committee, effective May 10, 2021. Wim Souverijns has served as Chief Commercial Officer of ObsEva since November 2018 and will leave the Company on June 30, 2021 to pursue a new opportunity.…

Menopause: TherapeuticsMD Launches a Bold, New Campaign Promoting Imvexxy, Its Estrogen Softgel Insert That Treats Vaginal Dryness

“Your vagina is queen. Imvexxy is her ally. Long may she reign.” Imvexxy by TherapeuticsMD is the only bio-identical estrogen softgel insert available today. It was first approved in May 2018, when the drug launched with a small campaign. Last week, however, Imvexxy, made a comeback with a bold, new campaign: “Reign”. The new video ad is period-drama (think Bridgerton) inspired and…