News
HRT maker censured by regulators for ‘systemic failures’ that risked patient safety

Theramex has been censured over HRT failures that regulators said jeopardised patient safety.
The UK producer of HRT drugs, including Evorel and Intrarosa, was found to have breached fundamental compliance standards.
These included not updating crucial prescribing information, in some cases for several years, and not making clear that one drug must not be used during pregnancy.
The Prescription Medicines Code of Practice Authority issued the public reprimand after Theramex staff blew the whistle over what it described as “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”.
Evorel patches, which contain estradiol, are among the most prescribed forms of transdermal HRT, meaning hormone treatment delivered through the skin. More than 250,000 items were issued in the last financial year, according to NHS Business Services Authority figures.
Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year.
The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019.
The PMCPA also reprimanded the company over failures to specify in advertising at a reproduction and advertising conference that Yselty, used to treat uterine fibroids, should not be taken during pregnancy.
In total, the PMCPA found Theramex had breached the Association of the British Pharmaceutical Industry’s code of practice 21 times.
The panel said the breaches not only jeopardised patient safety, but that Theramex had “brought discredit upon, and reduced confidence in, the pharmaceutical industry”.
The PMCPA also condemned Theramex’s decision to leave the regulator’s jurisdiction.
“By leaving the self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency to assume full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” it said.
Dr Amit Aggarwal, medical director of the ABPI, said: “Theramex has fallen seriously short of the standards expected under our strict ABPI code of practice, and it’s right that the PMCPA took action.
“It’s also disappointing that as a result, the company has decided to leave the pharmaceutical industry’s self-regulatory system, which holds companies to standards above and beyond the law.”
Julian Beach, MHRA’s executive director of healthcare quality and access, said he was disappointed Theramex had left the PMCPA, but that the MHRA would take any necessary steps to ensure patient safety.
He said: “Leaving the jurisdiction of the PMCPA does not mean a company escapes scrutiny.
“The MHRA has legal powers to investigate and act on concerns about medicines that may impact public safety. Breaches of regulations can amount to criminal offences.”
A spokesperson for Theramex said: “Upholding ethical standards, compliance, and patient safety is very important to us. We acted promptly to address these historical matters as soon as we became aware of them.
“We take these matters seriously and have undertaken a comprehensive review of our compliance framework, including commissioning an independent external audit and implementing a broad programme of enhancements.
“As part of this process, we concluded it is most appropriate to be regulated with respect to UK medicines legislation by the MHRA, while continuing to uphold the spirit and principles of the EFPIA and ABPI codes of practice.
“Therefore, we withdrew from the PMCPA’s jurisdiction in January 2026. This approach allows us to focus our resources on maintaining high standards of ethical and compliant behaviour, with patient safety.”
News
Menstrual health innovation shortlist revealed

We are thrilled to announce the shortlist for the Menstrual Health Innovation Award at the third annual FemTech World Awards.
This award, sponsored by Premom exists to celebrate the trailblazers redefining what menstrual health means in the modern world.
It recognises breakthrough products, services, and initiatives that are pushing boundaries in technology, product design, education, accessibility, and destigmatisation.
Premom’s innovative ovulation prediction app combines a digital ovulation test reader, intelligent fertility charting, and customised cycle insights to simplify the path to motherhood.
Sister company easy@Home was the first brand in the USA to offer personalised testing solutions and devices, and has become the largest volume seller of ovulation tests in the country.
Premom’s sponsorship of this award reflects a shared commitment to empowering women with better tools, better knowledge and better outcomes across every stage of their reproductive health journey.
This year’s shortlist is a testament to the remarkable breadth of innovation happening across the femtech landscape, from wearable bioelectronics to mission-driven apps reaching underserved communities across the globe.
Congratulations to the finalist and thank you to everyone who nominated.
Menstrual Health Innovation Shortlist
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Founded by healthcare designer Kateřina Rydlová, who wanted to manage her own period pain without relying on medication, Body Moody has developed a discreet, wearable heated bodysuit that delivers targeted warmth to the abdomen and back – quietly, under everyday clothing.
Made from soft viscose, controlled via a companion app, and built for 200+ washes and over five years of use, the bodysuit is as practical as it is pioneering.
Their borrow-then-buy model lowers the barrier to entry and early customer feedback speaks for itself, with users reporting that they have gone from averaging multiple painkillers per cycle to needing none at all.

Eshe is a women’s health ecosystem built for a part of the world that femtech has long overlooked.
Rooted in Sub-Saharan Africa, where 69 per cent of global maternal deaths occur, 65 per cent of women and girls in Kenya cannot afford sanitary pads, and over 60 per cent of women lack access to preventive healthcare, Eshe was created to meet women where they are.
The Eshe app offers daily menstrual cycle and fertility tracking, pregnancy monitoring, mental wellbeing check-ins, in-app consultations with qualified doctors, and health education content, all in one place.
By identifying irregular cycles, missed periods and mental health changes, the platform nudges users toward timely action rather than emergency intervention.

Polycystic ovary syndrome (PCOS) affects almost one in five women, making it the leading cause of infertility and a significant risk factor for conditions spanning obesity, cardiovascular disease, cancer, and cognitive decline.
Despite this staggering burden, there has not been a new treatment option in seven decades – until now.
LoOoP is a bioelectronic device paired with the MyLoOoP companion app, designed to address both the metabolic and menstrual symptoms of PCOS with the ultimate ambition of avoiding, delaying, or reducing its long-term complications.
The MyLoOoP digital platform goes further still, combining evidence-backed content, clinically validated journaling tools, a validated phenotyping algorithm, and an inclusive community – closing the persistent gaps in PCOS diagnosis, information and care.
What happens next
The shortlist will be judge by a Premom representative who will announce the winner at a virtual event on June 19.
The winner will receive a trophy and be interviewed by a Femtech World journalist.
Mental health
Dr-Julian helps deliver breakthrough mental health support for Black and ethnically minoritised mothers

A groundbreaking digital perinatal mental health pilot for Black and ethnically minoritised women has helped women access support faster, complete therapy at higher rates, and recover more successfully than national averages.
The partnership between digital tech company Dr-Julian and The Essential Baby Company Ltd within a new model of mental health care named haPPIE SHE Cares – who offer personalised support for women sharing their healthcare experiences, showed results well above NHS benchmarks for Black and ethnically minoritised women.
The pilot was created to help women who are less likely to use traditional mental health services during pregnancy and in the first year after giving birth.
By combining trusted community referrals, culturally aware support, and fast access to therapy through Dr-Julian’s online and virtual care platform, the programme delivered standout results.
Every woman who joined the pilot started therapy, 90 per cent completed treatment, and 74 per cent recovered; well above the NHS benchmark of around 52 per cent.
Women referred through community organisations accessed support in just one day on average, compared with around 21 days through many standard services.
Even the programme’s regular referral route reduced waits to 13 days.
The findings come as NHS leaders continue to focus on maternity inequalities and unequal access to mental health care.
Black and ethnically minoritised women can face barriers including stigma, language needs, lack of trust in services, childcare pressures, and difficulty navigating complex systems.
The haPPIE SHE Cares model was designed to break down those barriers by working with trusted community groups, offering culturally informed support, and where possible matching women with therapists who understood their background or language.
Gemma Poole for The Essential Baby Company said: “Too many women who need help feel unseen, unheard or unable to get support when they need it most.
“This project shows that when services are built around trust, culture and community, women engage, recover and thrive.
“This early success could provide a blueprint for reducing inequalities in maternal mental health care across the UK. Behind every statistic is a mother who felt supported, a family that benefited and a woman who found her voice.
“Mental healthcare must work for every community. This partnership shows that when high-quality therapy is combined with culturally responsive support, outcomes improve and women get help faster.
We are proud to have provided the therapists, virtual care systems and digital pathways behind this programme. We believe this model could help NHS organisations nationwide cut waiting times and improve recovery rates.”
Women who took part described the programme as life-changing, saying it reduced isolation, gave them confidence speaking with healthcare professionals, and made them more willing to seek help.
With growing pressure on maternity and mental health services, leaders behind the project say the pilot offers a practical solution that improves care while helping cut long waiting lists.
Plans are now being explored to expand the model through training, regional partnerships, and future funding.
Diagnosis
Women unaware of gynaecological cancers

Only one per cent of women can name all five gynaecological cancers, new research suggests, as 21 women in the UK die every day of the diseases.
The report also found that 31 per cent of women have put off or avoided seeking medical advice for gynaecological symptoms.
It also found that 43 per cent of women invited for cervical screening said barriers had put them off attending, while 18 per cent of respondents aged 25 to 34 who had been invited had never attended.
The five main gynaecological cancers are womb, also called uterine, ovarian, cervical, vulval and vaginal cancer.
The Lady Garden Foundation said that, while progress has been made since the UK government’s 2022 Women’s Health Strategy aimed to improve gynaecological cancer care, significant challenges remain.
John Butler, medical director and trustee at the Lady Garden Foundation, said: “The fact that only one per cent of the population can name the diseases that directly affect half of us underscores a significant awareness gap, impacting individuals’ ability to recognise vital signs and symptoms or seek timely medical help.
“Addressing this isn’t just about awareness; it’s a critical public health priority. Our collective efforts are essential to ensure the latest commitments announced by this government translate into tangible change that saves lives.”
The report said key reasons for delaying medical advice included difficulty making appointments, embarrassment and, for cervical screening, fear of pain or previous bad experiences.
Women also reported challenges within healthcare interactions, including feeling “not taken seriously”, “dismissed” or “not believed” when seeking gynaecological advice.
Jenny Halpern Prince, chief executive and charity co-founder, said: “We frequently hear reports of women feeling ‘not taken seriously,’ ‘dismissed,’ or ‘not believed’ when seeking gynaecological advice.
“These experiences highlight crucial areas where we can improve patient support and trust within our healthcare system, ensuring women receive the empathetic and effective care they need.”
The Lady Garden Foundation said it aims to increase awareness of both the charity and the five gynaecological cancers.
It also aims to serve as a primary entry point for reliable, stigma-free information, helping people understand their bodies, recognise symptoms and overcome barriers to accessing care.
Its Silent No More Garden was unveiled at the RHS Chelsea Flower Show 2026. Designed by Darren Hawkes, the garden serves as a national call to action, using five sculptures to spark conversations, break long-standing taboos and encourage open dialogue about symptoms and preventative care.
Butler said: “Continued focus and collaborative action are essential to progress.
“The ongoing commitment from the government, alongside societal efforts to break down taboos surrounding gynaecological health, are crucial.
“The Lady Garden Foundation is dedicated to being a beacon of information and support, empowering women with the knowledge they need. We urge everyone to learn the signs, speak up, and help us save lives.”
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