The US FDA considered mitochondrial replacement therapy during 2014 hearings

The first child born via mitochondrial replacement therapy was born in 2016

The healthy baby boy's mother carried genes for a rare mitochondrial disease called Leigh syndrome and after multiple miscarriages the family opted to try the controversial procedure. It was conducted by a US doctor in Mexico. The procedure is prohibited in the United States.

See how to make a baby with 3 parents, a process called mitochondrial replacement therapy

This primer video dives into the science of mitochondrial disease risks, how this controversial mitochondrial replacement technique can work, and why proponents say this reproductive advance—already legalized in the UK and Australia—is needed in the United States.

Eight British children have been born via mitochondrial replacement therapy

In July 2025, a decade after British lawmakers signed off on allowing three-parent IVF, scientists announced that eight healthy babies had already been born using this approach. The news was included in a pair of research articles published in a peer-reviewed journal that noted the oldest kids were already more than two years old, and that they were hitting developmental milestones as expected. (Some users may encounter a paywall.)

See this 201-level explanation about mitochondria and mitochondrial replacement therapy

This 2022 academic presentation from Stanford University's Dr. Gregory Enns offers a detailed overview about mitochondrial therapy approaches. Enns, a pediatric geneticist, explains how well-functioning mitochondria support the human body.

Four frozen embryos in the US were created via 3-parent IVF technique

Columbia University researchers created four embryos using mitochondrial replacement therapy for four female patients who didn't want to pass on mitochondrial diseases to their children. Yet US law restricts the researchers from implanting the embryos so they remain frozen. (Some users may encounter a paywall.)

Australia legalized 3-parent IVF in 2022

It was the second country, after the UK, to legalize the procedure, which is still prohibited in the US. There are more than 300 rare mitochondrial diseases that can be passed from a mother to her offspring.

Mitochondrial DNA swapping can occur before or after fertilization

Mitochondrial replacement therapy can be conducted with four different techniques, with varying genetic material transferred depending on the approach. Maternal spindle transfer, one common method, involves transplanting the nuclear DNA from a mother into an unfertilized egg from a donor. The donor egg is then fertilized and implanted into the mother's uterus using in vitro fertilization. Another major approach, pronuclear transfer, does the genetic swapping after the mother's egg has already been fertilized. This order of operations may be uncomfortable for some individuals, but the success rate with this technique is higher.

In 2026, the FDA proposed a novel approach to expedite reviews of gene therapies for patients with rare genetic disorders such as cystic fibrosis, potentially bypassing the need for years-long clinical trials if approved.

Without 3-parent IVF, women carrying faulty mitochondrial DNA have few options for children

Women who are carriers of mitochondrial diseases that wish to have children without those conditions cannot be biological parents without three-parent IVF. The alternatives are to adopt or have a child via egg donation.

3-parent baby approach may help women with infertility

Though the topline promise of this approach is avoiding passing on mitochondrial diseases, some researchers and companies have been eyeing its potential for helping with female infertility, since faculty mitochondria may contribute to the condition. Recent research suggests this approach could be promising.

3-parent IVF removes most—but not all—faulty mitochondria

The process scoops out about 99% of the mother's mitochondrial DNA—replacing it with that of a donor woman—but because that roughly 1% is still in the system there is still a small chance of disease for the resulting child or future generations. (Some users may encounter a paywall.)

The US FDA recently tried to regulate the expanded prenatal genetic tests

The agency proposed a new rule in 2023 to make it explicit that these types of tests are devices under existing law and clarify that that the agency could move to regulate them. They finalized a regulatory change in 2024 that added the words "including when the manufacturer of these products is a laboratory" to an existing law, but a federal district court vacated that edit in March 2025—returning the law to as it was before.

Roughly 1 in every 4,300 individuals in the US has mitochondrial disease

Roughly 1,000 to 4,000 kids are born with these conditions each year in the US though many of the diseases are fatal. Mitochondrial disorders often affect the organs that require the most energy, including the heart, brain, and muscles.

A planned clinical trial to treat a rare lysosomal storage disorder in utero has buoyed hopes of providing prenatal gene therapies, but it was still awaiting FDA approval to begin enrolling patients as of May 2026.

IVF is legal across America, but some worry that state bans could curtail this reproductive technology

This reproductive technology is available across the US, but if states take action to prohibit the discarding of unused embryos or pass related legislation, it could affect access to IVF. Laws prohibiting IVF or effectively outlawing the procedure by defining personhood as being conferred at the moment of conception have been under discussion in several states in recent years, including Ohio, Virginia, and Texas.

See this list of FDA-approved gene therapies, including offerings for inherited conditions as well as some forms of cancer.

CRISPR can't fix faulty mitochondria

Gene editing via CRISPR could theoretically fix many issues in biology, but editing the mitochondrial genome has remained challenging. In recent years, there has been some progress reaching these cellular powerhouses. (Some users may experience a paywall.)

How to consider the ethics of 3-parent IVF, which is illegal in the US

Ethical concerns with this controversial procedure include that a little bit of a child's offspring would be from a third person and that the decisions made with this pregnancy will affect numerous generations, making a permanent change to the gene pool.

In 2023, the FDA approved gene therapy for sickle cell disease, enabling one-time infusion bespoke treatments that use a patient's own stem cells to effectively cure a painful condition that disproportionately affects people of African American descent.

US federal researchers are blocked from putting certain human cells in animals

In 2015, US policymakers put a halt to any government-funded work that would insert human stem cells into animals. The reasoning was that human cells might spread through the animal's body and perhaps to its brain, blurring the line between humans and nonhumans. The ban remains in place today even as gene-edited pig parts are being placed in humans.

New eye implant clinical trial recruiting in 2026

University of Southern California researchers have launched a phase 2b clinical trial of a stem cell implant designed to restore vision in people with advanced dry macular degeneration. Patients will be randomized to receive the stem cell implant or a simulated procedure and placebo implant. This type of larger, second-stage clinical trial is designed to confirm efficacy and dosing and to look for side effects. It's one of the stages that precedes the US Food & Drug Administration approval of a device.

The FDA rejected MDMA-assisted therapy for PTSD in 2024, calling for more research

The decision was considered to be a major setback for moving psychedelics into the mainstream for mental health treatment. Pharmaceutical company Lykos, who had applied for the approval, had already attracted significant support from patients, politicians on both sides of the aisle, and leaders in the mental health field.

A 2024 court ruling has had ripple effects for frozen embryos

The Alabama Supreme Court's 2024 ruling that embryos created through IVF are legally children has had a chilling effect on the fertility industry. A few centers for reproductive assistance paused egg fertilization, and others are questioning where the legal argument will lead. The decision has some surprising implications for the future of IVF technology, including techniques that haven't yet been invented.

Scientists using gene therapy recently managed to regenerate retinal cells in the lab—a breakthrough for mammals that could potentially lead to future treatments for human retinal diseases.

Scientific advances are unlocking a wide range of alternatives to IVF

From refined artificial insemination and microsurgical sperm extraction to experimental uterine transplants, scientific innovation is rapidly advancing potential fertilization technologies. But they come along with costly trials, some ethical dilemmas, regulatory issues, and more.

Selecting an embryo based on polygenic score is illegal in the UK, Israel, and swaths of Europe

Though their use for embryo selection is illegal in many locations, private clinics in the US may offer polygenic scores to inform embryo selection. The US Food and Drug Administration has not banned their use—instead the tests are regulated like supplements, meaning they are not regulated before they come to market but consumers can file complaints and then the agency may take action.

Gene therapy, a hope of the Human Genome Project, has successfully treated a baby born with a rare urea cycle disorder that causes toxic ammonia level buildup.

The first CRISPR-approved treatment was for sickle cell anemia in 2023

Victoria Gray was the first patient to receive a CRISPR-based therapy, which eliminated her symptoms and restored her health. The therapy's initial cost of $2.2M has kept it out of reach of many patients.

A new daily MS pill is seeking regulatory approval in 2026

In clinical trials, Roche's fenebrutinib showed promise treating primary progressive MS and doubling relapse-free time in patients with relapsing MS as compared to existing treatment. But some liver damage and two possible drug-related deaths in the trials may make it difficult for the drug to net approval. (Some users may encounter a paywall.)

A single-gene mutation in the FOXC2 gene gave actress Elizabeth Taylor two rows of eyelashes.

About 250,000 patients accessed assisted reproductive technologies in 2022

In 2022, 251,542 patients tried assisted reproductive technologies—most commonly IVF—resulting in more than 98,000 infants. Those children represent around 2.6% of the babies born in the US.

‘Hope for Healing’: The first-ever use of an in utero stem cell treatment

In 2023, researchers at UC Davis performed the first-ever fetal stem cell transplant, attempting to cure a case of spinal bifida prior to childbirth using stem cells derived from the placenta. The trial, and others including an effort to treat muscular dystrophy, highlight the potential power of stem cell therapy.

US regulators have approved an at-home genetic test looking for BRCA gene mutations

The direct-to-consumer genetic test, approved by US regulators in 2018, examines 3 out of the more than 1,000 known breast cancer-linked genetic mutations. It looks for genetic variations that can increase risk for breast, ovarian, and other cancers. These mutations are most commonly found among Jewish people with Eastern European ancestry.

As of February 2025, there are more than 150 clinical trials using CRISPR technology

The clinical trials are designed to determine whether experimental CRISPR-related therapies are safe and effective. The majority of trials involve treatments for blood disorders, including beta thalassemia.

The US FDA issued a 2025 warning about BPC-157 and other popular peptides that are marketed for various regenerative properties.

How personalized gene-editing saved a baby's life

KJ Muldoon had a 50% chance of surviving a genetic mutation until doctors developed a one-of-a-kind gene-editing therapy. In an interview with one of the researchers behind the treatment, learn what it will take to make personalized genetic medicine possible for everyone.

FDA has removed black box warnings from hormone replacement therapy for menopause.

IVF was long considered controversial and ethically dubious

In spite of its wide acceptance as a form of reproductive assistance today, and its role in helping millions of people have children, in vitro fertilization was once considered a controversial threat to society. One magazine went as far as to describe the procedure as "the biggest threat since the atom bomb."

A physician with a rare and deadly disease saved his own life by identifying an existing medication that he repurposed for his condition, and now he's using AI to try to do the same for other patients.

As of 2025, perfect synthetic replication of natural organs remains elusive

Advancements such as 3D printing muscles, performing vaginal reconstruction with colon tissue, and growing organs in a lab have shown promise, but artificial options and transplanting substitutions continue to exhibit functional and performance limitations compared to their natural equivalents.

27% of US menopausal women used estrogen in 1999, but by 2020 that number was under 5%

The fallout of studies in the early 2000s linking hormone therapy for menopause and elevated cancer, stroke, and other health risks meant that even decades later—yet before the FDA removed its black box warning in 2025—use of HRT remained extremely uncommon. (Some users may experience a paywall.)

FDA removed its cardiovascular risk warning on testosterone products in 2025

The change came a decade after the FDA added the label. Recent work, including a gold-standard randomized trial, found that men receiving the products had similar cardiovascular risk levels as men taking placebo products. Testosterone, however, may hold other health risks, including infertility.

Peptides like GLP-1 account for 31 of 370 new drugs approved by the US FDA between 2016 and 2023.

Gene therapy for a rare type of deafness is allowing deaf children and adults to hear for the first time, according to research results reported in April 2026.

3-parent baby technique fuels worries of future 'designer babies'

Some critics of this approach worry that any genetic manipulation will both culturally and technologically normalize the idea of "designer babies"—embryos that are manipulated or selected based on physiological characteristics including height, eye color, athletic ability, and intelligence.

Australian psychiatrists already prescribe psilocybin and MDMA for depression and PTSD

The country green lighted the treatments for July 1, 2023, onward, with MDMA—ectasy—as a post-traumatic stress disorder treatment, and psilocybin—magic mushrooms—as an option for people with treatment-resistant depression.

Indefinite cloning of some endangered species may not sustain their longevity because cloning success rates decrease as genetic mutations accumulate.

In vitro gametogenesis: using induced stem cells to fertilize eggs

Using stem cells from skin and mouth cells could save hopeful parents time and money and spare egg donors from significant amounts of discomfort throughout the process. There are potential consequences, not just for infertility treatment, but for the ability to create customized cells of any type.

Oregon voters in 2020 greenlit adult use of psilocybin—the active ingredient in magic mushrooms—in state-licensed centers, and a 2026 analysis indicates the program has good safety and satisfaction data.

How two families navigated an unthinkable IVF mistake

The field offers hope to thousands of families annually, but it is also largely unregulated, and for a small number of parents, things can go terribly wrong.