The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome.

The co-founders of Zero Candida Ltd. described, in the company’s first PCT filing, their development of a drug-free solution for treating vaginal fungal infections using an intravaginal light-based treatment device (ILTD) that projects light at predefined intervals and intensities to treat infection.

Celmatix Inc. and Aché Laboratórios Farmacéuticos SA will study the role of melatonin receptors and their agonists in polycystic ovary syndrome (PCOS). The two companies announced a collaboration, with a separate license and development agreement upon conclusion of the research.

Sonio SAS closed its series A fundraising round raising $14 million that will go some way in helping the company deliver on its mission to improve access to quality pregnancy monitoring for women everywhere through its software-as-a-service (SaaS) platform. Sonio has developed an artificial intelligence (AI) prenatal screening solution that automates ultrasound reporting while providing image quality control and detection of potential anomalies. The capital raise was led by Cross-Border Impact Ventures, a North American impact fund dedicated to the health of women and children.

The €5.5 million (US$6 million) Escala Medical Ltd. recently received from the European Innovation Council will help the company expand its operations as it looks to officially launch its Apyx device in the U.S. later this year, CEO and founder Edit Goldberg told BioWorld. Already FDA-cleared, Apyx offers incision-free pelvic organ prolapse (POP) treatment to the women suffering from the often painful and debilitating condition.

Difficulty in obtaining an accurate diagnosis and treatment for endometriosis leaves many women spitting mad, but they may soon find that saliva is the key to escaping the diagnostic maze. A recent study published in the New England Journal of Medicine validated the Endotest developed by Ziwig SAS based on results from a study involving 200 symptomatic patients monitored in five hospital units and specialized centers in France since November 2021. The findings demonstrated a sensitivity and specificity of more than 95%.

A new study from Dana Farber Cancer Institute, Brigham and Women’s Hospital and Poland’s Medical University of Lodz suggests a simple blood test could detect ovarian and breast cancer without the need for genetic sequencing, paving the way for broader and less costly screening campaigns.

A new study has shown that a uterine bacterium is one cause of endometriosis and that preventing the infection could prevent development of the pathology, in which tissue similar to the lining of the uterus grows in the abdominal cavity.

The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.

The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.