In a landmark development for patients who live with a rare and painful skin condition, the US Food and Drug Administration or the FDA has approved Zevaskyn (prademagene zamikeracel) for the treatment of recessive dystrophic epidermolysis bullosa or RDEB. This is an inherited disorder that causes the skin to be extremely fragile. I also leads to chronic wounds, bleeding, and tearing even from minor friction or trauma.

As per the 2015 study published in the Journal of Clinical and Aesthetic Dermatology, there are four major subtypes of the skin disorder, which comes from the heterogeneous group of inherited mechanobullous disorder hat is caused by mutation in genes that encode structural proteins in the skin. The overall condition is referred to as epidermolysis bullosa, and one of its type is RDEB, which further comes with two main subtypes of dystrophic EB.

Zevaskyn is now the first and only autologous cell-based gene therapy approved for both adult and pediatric patients living with this life-altering condition.

Why Is This A Breakthrough In Gene Therapy?

Zevaskyn represents a new era in wound care and gene therapy. Unlike traditional treatments that only manage symptoms, this one-time surgical application targets the underlying genetic mutation responsible for RDEB. The therapy uses the patient's own skin cells, which are genetically modified to produce a functional version of the missing COL7A1 gene, critical for anchoring skin layers together.

"Zevaskyn is not just a bandage—it’s a breakthrough that may help change the course of this disease for many," said Madhav Vasanthavada, Ph.D., Chief Commercial Officer at Abeona Therapeutics, the biopharmaceutical company behind the treatment.

How Was It Approved?

The FDA based its approval from the results of two clinical trials: a phase 1/2a study and the pivotal phase 3 VITAL study.

Phase 1/2a Trial: In this study, seven patients with 38 chronic wounds received a single Zevaskyn application. Researchers observed a significant and long lasting improvement at treated sites during the median follow-up of seven years.

Phase 3 VITAL Study: This was a larger study that included 43 patients with large unhealed or non healing wounds. After six months, 81% of those wounds treated by Zevaskyn, showed at least 50% healing, as compared to only 16% in the control group, who had received the standard care.

These outcomes were not only statistically significant but also clinically meaningful, especially for patients who have previously struggled with limited treatment options.

Zevaskyn also showed a favorable safety profile across both studies. No treatment-related serious adverse events were reported. The most common minor side effects were procedural pain and itching, affecting approximately 5% of participants.

"This therapy offers hope for patients and families who have lived too long without effective solutions," said Vasanthavada. “We’re confident in Zevaskyn’s ability to deliver long-term results and are committed to making it widely accessible.”

Access For Patients

To ensure access, Abeona Therapeutics plans to collaborate with both commercial insurers and government payers. The company aims to develop outcome-based agreements that reflect the long-term benefits of a single application of Zevaskyn, reducing the need for repeat procedures or ongoing wound care costs.

With FDA approval, Zevaskyn is set to be a game-changer in the treatment of recessive dystrophic epidermolysis bullosa—offering patients more than just relief, but a meaningful step toward healing.

Kenvue, the American company behind Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label reflecting research about a possible link between its use during pregnancy and autism or ADHD diagnoses in children.

The company emphasizes that acetaminophen, the generic name for Tylenol, also called paracetamol is “one of the most studied medicines in history” and argues that adopting the proposed label warning would be arbitrary, capricious, and unlawful.

Tylenol generates roughly $1 billion annually for Kenvue and remains the company’s top-selling brand, according to Morningstar. The current label advises pregnant or breastfeeding individuals to “ask a health professional before use.”

Push for Label Change Sparks Attention

The call for a label change gained attention after former President Donald Trump held a news conference last month, telling pregnant women in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is widely considered the safest over-the-counter pain reliever during pregnancy.

Trump claimed, without evidence, that taking Tylenol during pregnancy is linked to a “very increased risk of autism.” “Fight like hell not to take it,” he urged.

Most pregnant people use acetaminophen at some point, studies show. Other common pain or fever treatments, such as ibuprofen or regular-dose aspirin, can increase the risk of serious complications during pregnancy. Untreated pain or fever can also be dangerous, possibly leading to miscarriage, birth defects, or high blood pressure.

FDA and Public Health Actions

Beginning the process to change acetaminophen labels was one of several steps the Trump administration planned. HHS Secretary Robert F. Kennedy Jr. said his agency would also launch a public service campaign about the issue.

The FDA sent a letter to physicians noting that the decision to take Tylenol “still belongs with parents,” while also warning that its use during pregnancy may carry an “increased risk of neurological conditions such as autism and ADHD in children.”

However, the letter stressed that “a causal relationship has not been established” and that studies examining a potential link are “contradictory,” as per CNN.

Citizen Petition Filed

The Informed Consent Action Network, an anti-vaccine nonprofit closely tied to Kennedy, filed a citizen petition with the FDA on the same day as Trump’s news conference. Citizen petitions allow individuals, industry groups, or consumer organizations to request FDA action on specific issues.

The petition claimed that, because of “urgent public health implications,” the FDA should add a warning to acetaminophen labels stating that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder.”

Kenvue Responds

On Friday, Kenvue formally asked the FDA to deny the petition, saying that the proposed label changes are unsupported by scientific evidence and would represent a departure from the FDA’s longstanding position on acetaminophen during pregnancy. The company said it had met with Kennedy in early September after he suggested a link between acetaminophen use during pregnancy and autism, and Kenvue informed him there was no such connection.

FDA Guidance and Global Response

The FDA website on acetaminophen has not been updated to reflect the Trump administration’s views. The last update, in August, states, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.” Acetaminophen has been studied for decades, and according to the American College of Obstetricians & Gynecologists, no reputable study has concluded that its use in any trimester causes neurodevelopmental disorders in children.

Following Trump’s news conference, medicine regulatory agencies in the European Union, United Kingdom, and Canada quickly released statements confirming that acetaminophen remains safe for pregnant individuals.

Vision impairment is an issue that many people don’t understand. Most people view vision loss as absolute, either you can see or you cannot. However, there are other conditions where a person has slightly less vision and also severe visual impairment. According to the World Health Organization (WHO), 2.2 billion people in the world have near or distance impairment and according to their statistics, 1 billion of these cases could have been addressed. Taking a step towards this same cause, a new technology has been created, which could help people who have slowly lost their sight to read again.

A new study has been published in The New England Journal of Medicine, announcing a huge step forward for people with Age-Related Macular Degeneration (AMD). This is a common disease that causes people to lose their central vision over time. The groundbreaking result of the study was that dozens of patients who took part in the study were able to get some of their sight back. This was achieved by using a brand-new system that combines an eye implant with special smart glasses.

Also Read: Can You Get Your Covid And Flu Shots At The Same Time? Experts Explain

This technology was powerful enough to help these patients return to doing simple, everyday things they could no longer do, like reading books or solving crossword puzzles. The people who participated in this trial were all 60 years or older, had AMD in both eyes, and had very poor vision in the eye being studied.

How Can You Help Someone With Progressive Vision Loss?

To understand why this is a big deal, you need to know that AMD causes the cells in the center of the retina (the light-sensitive part at the back of the eye) to die. Once they die, vision loss is considered permanent. This new study doesn't cure AMD, but it focuses on replacing the job of those dead cells to bring some vision back. The system has two main parts:

The Implant

This is a tiny device, only about 2x2 millimeters in size, which is smaller than a small pea. It’s made of little photovoltaic solar panels. It is carefully surgically placed underneath the patient's retina.

The Smart Glasses

The patient wears these special glasses, which have a camera. The glasses capture a close-up, zoomed-in image of the world and send this image to the implant using near-infrared light.

Once the implant receives the light signal, it creates small electrical pulses. These pulses travel to the optic nerve, completely taking over the job of the dead retinal cells and allowing the brain to finally see the world again.

How Does This Technology Work?

The clinical trial started with 38 patients who got the implant. After one full year, 32 patients were still involved in the study. The results at the one-year mark were extremely encouraging:

26 out of the 32 participants, which is an 80 percent success rate, could see better than they did when they started the trial.

It’s important to note that the vision they regained isn't perfect; patients can only see a blurry image and everything is in black and white. However, outside experts have praised the achievement, with some calling the work "amazing," because it provides hope where there was previously none.

The technology was developed by a company called Science Corporation, which works on brain-computer interfaces. The CEO and founder of Science Corporation is Max Hodak, who also helped start the well-known neurotechnology company Neuralink with Elon Musk back in 2016.

Science Corporation took over this vision project in 2024. They acquired the retinal implant technology from a French company named Pixium Vision. Pixium Vision had spent ten years trying to develop the technology but eventually ran out of money. This kind of "rescue" is actually not unique in the medical world; a similar situation happened with another company, Second Sight Medical, whose abandoned vision technology was also saved by a different startup to keep its clinical trials going.

A landmark study titled “COVID-19 Vaccine Linked to Longer Survival in Cancer Patients” has revealed that people with advanced lung or skin cancer who received an mRNA COVID-19 vaccine within 100 days of starting immunotherapy lived significantly longer than those who did not. Conducted by researchers from the University of Florida (UF) and the University of Texas MD Anderson Cancer Center, the findings were presented at the 2025 European Society for Medical Oncology Congress in Berlin and mark a major step in exploring how mRNA technology could strengthen cancer treatment.

A Milestone in mRNA Research

This study represents the culmination of more than a decade of UF research on mRNA-based cancer therapies. Lead investigator Dr Elias Sayour, a pediatric oncologist at UF Health, called the findings “extraordinary,” noting that the vaccine’s immune-boosting effect could help design a universal, off-the-shelf cancer vaccine capable of enhancing immunotherapy responses.

mRNA, or messenger RNA, is a molecule that carries genetic instructions to make proteins. It forms the basis of COVID vaccines developed during the pandemic, and scientists now believe this same mechanism could be harnessed to amplify the body’s cancer-fighting abilities.

How the Study Was Conducted

Researchers analyzed medical records of over 1,000 patients with stage III and IV non-small-cell lung cancer or metastatic melanoma treated at MD Anderson between 2019 and 2023. Of these, 180 lung-cancer patients and 43 melanoma patients received a COVID-19 mRNA vaccine within 100 days of starting immunotherapy. Their outcomes were compared with 704 and 167 unvaccinated patients, respectively.

The results were striking. Vaccinated lung-cancer patients showed a median survival of 37.3 months, nearly double the 20.6 months observed in unvaccinated counterparts. Among melanoma patients, survival rose from 26.7 months to about 30–40 months, with several patients still alive at data cut-off — suggesting an even greater long-term benefit.

Importantly, the effect was specific to mRNA COVID vaccines; flu and pneumonia shots did not produce similar outcomes.

The Science Behind the Boost

Earlier this year, Dr Sayour’s lab discovered that to trigger a strong immune attack, targeting a single tumor protein wasn’t necessary. Instead, stimulating the immune system as if fighting a viral infection worked better. When this nonspecific mRNA vaccine was combined with immune checkpoint inhibitors — drugs that “release the brakes” on immune cells — mice showed powerful antitumor responses.

Building on this, the team theorized that the COVID mRNA vaccine might act like an immune flare, mobilizing immune cells from tumor zones to lymph nodes where cancer defense is stronger. This mechanism, Sayour explained, could make previously unresponsive cancers respond to treatment.

Implications and Next Steps

Although this is an observational study and cannot yet prove causality, experts are optimistic. UF’s Dr Duane Mitchell emphasized that while more trials are needed, such a large survival benefit “is the type of treatment effect we rarely see.”

A large-scale clinical trial through the UF-led OneFlorida+ Research Network is now planned to verify these findings across hospitals in several U.S. states.

If confirmed, the discovery could reshape how cancer is treated — turning vaccines from preventive tools into active partners in therapy. For patients battling advanced cancers, this could mean something profoundly valuable: more time and renewed hope.