Rejoni receives FDA approval for Juveena Hydrogel System 🔬
Rejoni has received FDA Premarket Approval for the Juveena Hydrogel System, the first approved treatment specifically designed to reduce intrauterine adhesion formation following hysteroscopic adhesiolysis for moderate to severe intrauterine adhesions. Delivered transcervically as a liquid that forms in situ and naturally discharges within 14 to 21 days, Rejoni is now launching at select US centres before a broader commercial rollout.
"For women with moderate to severe intrauterine adhesions, protecting the uterine cavity after surgery is critical. As an investigator in the Juveena pivotal study, I saw its impact on my patients firsthand, and I'm excited to now offer it as part of my standard of care."
— Pietro Bortoletto, Co-Founder, Terra Fertility
Bayer's Lynkuet receives FDA Priority Review for hot flashes in breast cancer patients on endocrine therapy 💊
Bayer's non-hormonal hot flash treatment Lynkuet (elinzanetant), already FDA-approved for menopause-related hot flashes since October 2025, has been granted Priority Review for a new indication covering moderate to severe vasomotor symptoms in women receiving endocrine therapy for HR+ breast cancer. The sNDA is based on the Phase III OASIS-4 trial, in which Lynkuet met primary endpoints of reducing hot flash frequency and severity at weeks 4 and 12 versus placebo.
“Currently, there are no FDA approved treatment options for moderate to severe vasomotor symptoms associated with endocrine therapy in patients with HR+ breast cancer in the U.S. This treatment gap underscores an important unmet medical need for this population. As a global leader in women’s healthcare, this priority review is an important milestone for Bayer and underscores our commitment to women’s health and making treatment options available.”
— Kristie Baisden, Vice President, U.S. Medical Affairs, Women’s Health, Bayer
Flora Fertility and Clue partner to connect cycle tracking with fertility insurance planning 🌸
Canadian fertility insurance startup Flora Fertility has partnered with period and cycle tracking app Clue, connecting reproductive health education with financial planning for future fertility care. Clue will introduce its members to Flora's fertility insurance offering - policies covering up to $50,000 in fertility services including diagnostics, IUI and IVF, while new and existing Flora policyholders receive complimentary access to Clue Plus, which provides advanced cycle insights and pattern analysis.
"Clue has created a trusted space where women are already learning about their bodies and taking a more active role in their health. By bringing FLORA into that experience, we can help women turn what they are learning into a plan for the future. Clue provides the insights to understand their reproductive health, while FLORA gives them a way to prepare financially for fertility care they may need later."
— Dr. Christy Lane, Co-Founder & Co-CEO, Flora
Dare Bioscience secures new US patent strengthening DARE-HPV program 🧬
San Diego-based Dare Bioscience has been issued US Patent No. 12,678,439 covering pharmaceutical compositions of lopinavir and ritonavir for topical treatment of HPV-related cervical pathologies, the underlying technology behind its DARE-HPV program. The patent, which provides protection into at least 2039, adds IP protection at a pivotal point in the programme's development. Millions of women experience high-risk HPV infection each year in the US, yet there is still no FDA-approved pharmacologic treatment to clear the infection.
“This patent adds another important layer to the foundation we are building around DARE-HPV at a particularly exciting point in the program’s development. Millions of women experience high-risk HPV infection each year in the United States, yet there is still no FDA-approved pharmacologic treatment to clear the infection. we believe DARE-HPV represents a compelling opportunity to address a significant unmet need in women’s health"
— Sabrina Martucci Johnson, President & CEO, Daré Bioscience
Freyya closes oversubscribed pre-seed to advance pelvic health tech toward FDA clearance 💪
San Antonio-based Freyya has closed an oversubscribed pre-seed round led by Alamo Angels to fund its FDA submission and commercialisation preparation. Freyya has completed product development and its ERICA clinical study at the University of Utah, and has engaged a contract manufacturer for commercial-scale production. Its ergonomic, biosensor-integrated pelvic floor platform is designed to deliver data-driven, personalised pelvic health therapy for women recovering from childbirth, injury or hormonal changes.
“This financing gives Freyya the resources to stay focused on the milestones that matter most: completing our FDA submission, advancing through the regulatory process, and preparing for commercialization. We are grateful to the investors who participated, not only for their confidenc e in Freyya, but also for recognizing the need for continued innovation and investment in women’s health.”
— Dr. Gabriele Niederauer, CEO & Co-Founder, Freyya
Newcastle physiotherapist secures £75,000 to build AI-powered pelvic health app 🏃
Suzanne Vernazza, an NHS physiotherapist from Newcastle, has received £75,000 from Innovate UK's Women in Innovation programme to develop and clinically validate Know Your Floors, a pelvic health app combining daily pelvic floor exercises, gamification and an AI-supported symptom information tool. Vernazza runs #SqueezeAlong, an online pelvic health community with over 670,000 followers. The app enters beta testing in December 2026, targeting a condition that affects around one in three women but is still largely driven by embarrassment and poor information access.
"This funding is transformational for the project. It allows us to move from an idea with strong clinical foundations and community support to a properly tested, launch-ready product. We will be able to work alongside beta testers to refine the experience and carefully validate the AI-supported information feature, so we're building something that is not only innovative, but clinically robust and worthy of people's trust."
— Suzanne Vernazza, Founder, Know Your Floors
