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exeltis slynd oral contraceptive tablet

Exeltis USA announces the approval of Slynd™

Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd™ (pronounced “slind”) containing drospirenone 4 mg, an oral contraceptive tablet for pregnancy prevention.

Slynd™, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive that is intended as a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window. This not only can mean favorable safety and efficacy but an improved…

Evofem Biosciences, Inc. clinical trial of Amphora

Evofem Biosciences Reports Additional Data from Phase 3 ‘AMPOWER’ Study of Amphora® for Hormone-Free Birth Control

Evofem Biosciences, Inc. (NASDAQ: EVFM) (Evofem), a clinical-stage biopharmaceutical company, today reported additional data from its Phase 3 ‘AMPOWER’ clinical trial of Amphora® for the prevention of pregnancy. These findings reveal that the use of Amphora, a first-in-class investigational Multipurpose Vaginal pH Regulator (MVP-R™), may improve sexual satisfaction and have a positive impact on women’s sex lives.  The analysis also confirmed certain previously reported safety and efficacy data…

velicept solabegron overactive bladder (OAB)

Velicept Therapeutics Announces Positive Top-Line Phase 2B Results for Solabegron in the Treatment of Overactive Bladder (OAB)

Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a Phase 2b study in patients with overactive bladder (OAB). In the study, twice-daily administration of solabegron demonstrated…

scynexis Phase 3 VANISH 303 Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (VVC)

SCYNEXIS Completes Last-Patient/Last-Visit Ahead of Schedule in the First Phase 3 Study (VANISH 303) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (VVC)

SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced completion of the last-patient/last-visit in its Phase 3 VANISH 303 study, and that it expects to release top-line data earlier than previously reported. Ibrexafungerp (formerly SCY-078) is the first…

GTX ASTRID urinary incontinence (SUI)

GTx Announces Top-Line Results from Placebo-Controlled ASTRID Trial of Enobosarm in Women with Stress Urinary Incontinence

GTx, Inc. (Nasdaq: GTXI) today announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with stress urinary incontinence (SUI), did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to placebo. The percentage of patients with a greater than 50% reduction after 12 weeks…

Myovant Sciences Combination Therapy in Women with Uterine Fibroids

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

Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing and commercializing innovative therapies for women’s health and prostate cancer, today announced that LIBERTY 2, the second of two Phase 3 studies of once-daily relugolix combination therapy, met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids…