News
FDA orders the market withdrawal of the only US premature birth drug
The move marks the first time the FDA has formally forced the removal of a drug

The Food and Drug Administration has ordered the immediate market withdrawal of the only drug intended to prevent premature births in the US.
The drug, which remained available on the market for years despite data showing it was not effective, was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries, according to ABC News.
The decision to withdraw it follows efforts by the pharmaceutical company Covis Pharma to keep Makena on the market while additional studies emerged.
In recent months, however, the drugmaker bowed to FDA pressure, proposing a “winding down” period of several months so that women taking the drug could complete their treatment.
The FDA rejected the proposal and said that the action against Makena and several generic versions should take effect immediately.
The decision by FDA Commissioner, Robert Califf, and the agency’s chief scientist marks the first time the FDA has formally forced the removal of a drug that it initially approved based on promising early data.
In all prior cases, drugmakers voluntarily pulled medications after the FDA made clear it intended to order removal.
The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy.
The FDA expedited Makena’s approval in 2011 based on a study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term.
However, results from a 1,700-participant study conducted in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.
The FDA has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.
In October, the company failed to convince a panel of outside FDA advisers that the drug should stay on the market for certain women.
Insight
Fertility rate in England and Wales hits record low, new figures reveal

The fertility rate in England and Wales fell to a record low of 1.39 children per woman in 2025, down from 1.41 a year earlier.
New figures show that parts of London and cities with major universities accounted for many of the areas with the lowest local fertility rates.
The City of London recorded the lowest rate in 2025 at 0.37 children per woman, followed by Cambridge at 0.87 and the London boroughs of Islington and Westminster at 0.90.
The Office for National Statistics (ONS) defines the fertility rate as the average number of live children women would expect to have over their childbearing lives.
Brighton & Hove recorded a rate of 0.95, followed by Southwark at 0.97 and Norwich at 0.98.
Exeter, Oxford and York, along with the London boroughs of Camden and Hammersmith & Fulham, each recorded 1.01 children per woman.
At the other end of the table, Pendle in Lancashire and Luton in Bedfordshire had the highest rate at 1.93.
They were followed by Oldham in Greater Manchester at 1.87, Bradford in West Yorkshire at 1.84 and Barking & Dagenham in London at 1.83.
The overall fertility rate for England and Wales declined from 1.41 in 2024 to 1.39 in 2025.
A rate of around 2.1 is needed for a population to remain stable over time when the impact of migration is excluded.
Twelve of the 25 local authorities with the lowest fertility rates in 2025 were in London.
In Wales, Swansea recorded the lowest fertility rate at 1.18, while Carmarthenshire, the Isle of Anglesey and Newport each had the highest rate at 1.48.
There were 585,396 live births in England and Wales in 2025, down from 594,677 in 2024 and the lowest number since 1977.
Live births fell across every region in England. The West Midlands recorded the largest percentage decline at 3.1 per cent, while the North East had the smallest at 0.3 per cent.
The average age of parents also increased slightly.
Mothers had a provisional standardised mean age of 31.1 in 2025, compared with 31.0 in 2024. Fathers had an average age of 34.0, up from 33.9.
In 1975, the average age was 26.4 for mothers and 29.5 for fathers.
The proportion of births where the mother was born outside the UK also increased, from 20.8 per cent in 2005 to 27.5 per cent in 2015 and 34.6 per cent in 2025.
India was the most common country of birth for non-UK-born mothers in 2025 for the fourth consecutive year.
It was followed by Pakistan, Nigeria and Romania.
In 2025, 56.4 per cent of births were to parents who were both born in the UK, down from 62.7 per cent in 2015.
Hormonal health
Menopause hormone therapy may improve cardiovascular health outcomes, study suggests

Hormone therapy started in peri- or early post-menopause was linked to a 22 per cent lower risk of cardiovascular events in women with vasomotor symptoms in a recent study.
The findings came from an observational analysis of 20 years of health data and do not show that hormone therapy caused the reduction in cardiovascular risk.
The association was strongest among Black women and women who started treatment within 10 years of menopause onset, although researchers cautioned that the findings should not guide clinical practice.
The study is the first of its kind in the US to assess the risk of future cardiovascular events among women with vasomotor symptoms who use hormone therapy during peri- and early postmenopause.
Samar R. El Khoudary, professor and chair of the Department of Epidemiology at the VCU School of Public Health and one of the study’s senior researchers, said: “The menopause transition represents a critical window for understanding how hormone therapy may relate to cardiovascular disease risk. Our findings suggest that timing of initiation may influence cardiovascular outcomes.”
The researchers stressed that the findings do not support using hormone therapy to prevent cardiovascular disease.
Potential benefits must also be weighed against risks, including the increased breast cancer risk observed with longer-term use.
The study was not a randomised controlled trial, the gold-standard method for testing biomedical treatments.
Rebecca C. Thurston, associate dean for Women’s Health Research at the University of Pittsburgh School of Medicine and one of the study’s senior researchers, said: “These findings point to women with vasomotor symptoms as those who may show cardiovascular benefit from hormone therapy initiated during the perimenopause and postmenopausal years.
“However, conclusions should be tempered by the observational nature of the study, and findings should not guide clinical practice.”
Vasomotor symptoms, meaning hot flushes and night sweats, affect up to 80 per cent of women during the menopause transition and last for an average of seven to ten years.
Their frequency and severity build through perimenopause and typically peak in early postmenopause.
Hormone therapy replaces oestrogen and progesterone that women’s bodies stop producing after menopause and is currently the most effective treatment for these symptoms.
Clinical trials led by the Women’s Health Initiative in the early 2000s raised concerns about hormone therapy’s impact on heart disease, stroke, breast cancer and other risks, leading to years of reluctance among patients and providers to use the treatment.
El Khoudary said: “Hot flashes and night sweats have a significant impact on a woman’s quality of life and ability to work productively.
“While hormone therapy is an effective treatment for these symptoms, questions have remained about its cardiovascular effects, particularly the importance of when treatment is initiated during the menopause transition.”
More recent research suggests the effects of hormone therapy on the heart and vascular system may vary by age and treatment timing, with women younger than 60 who start treatment closer to menopause onset having different levels of risk.
In 2026, the US Food and Drug Administration removed “black box” warnings from hormone therapy products, reflecting evolving evidence on the benefits and risks of treatment.
Researchers from Virginia Commonwealth University and the University of Pittsburgh analysed data from more than 2,700 women taking part in the Study of Women’s Health Across the Nation (SWAN).
The women reported vasomotor symptoms and had not previously experienced cardiovascular events.
Clinical data collected between 1997 and 2017 were used to examine whether women who started hormone therapy for vasomotor symptoms were more or less likely to experience stroke, congestive heart failure, heart attack or revascularisation procedures than women who did not start treatment.
El Khoudary said: “By using data from the SWAN study, we essentially were able to emulate a series of hypothetical clinical trials to gain a deeper understanding into how hormone therapy taken to mitigate vasomotor symptoms during peri- and early postmenopause influences cardiovascular risk over time.
“It allowed us to examine clinically meaningful cardiovascular disease events over long-term follow-up in a population and treatment window that has been challenging to study prospectively.”
Starting hormone therapy during peri- or early postmenopause was associated with an estimated 22 per cent lower risk of cardiovascular disease events.
Women who began hormone therapy within 10 years of menopause onset had an estimated 27 per cent lower risk compared with women who did not start treatment.
Among Black women, starting therapy during peri- or early postmenopause was associated with an estimated 49 per cent lower risk of cardiovascular disease events.
No clear reduction was seen among women who started therapy more than 10 years after menopause onset or among White women and other racial and ethnic groups.
El Khoudary said: “The differences in cardiovascular outcomes by race and ethnicity are notable, particularly because Black women are more likely to experience severe vasomotor symptoms.
“These findings highlight the need to better understand how hormone therapy timing may influence cardiovascular outcomes across diverse populations.”
It remains unclear why cardiovascular risk differed according to when hormone therapy was started, although researchers believe differences in blood vessel health with age may play a role.
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