FDA CDC News
FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa
Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the FDA’s ongoing commitment to supporting the development and evaluation of new treatments that address unmet needs for rare diseases or conditions.”
DEB is a genetic disorder that affects the connective tissue in the skin and nails and results from mutation(s) in the COL7A1 gene. This gene encodes type VII collagen (COL7), which is an essential protein that helps strengthen and stabilize the outer and middle layers of the skin. When COL7A1 is deficient, skin layers can separate, causing painful and debilitating blisters and wounds. DEB usually presents itself at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa (RDEB) and dominant dystrophic epidermolysis bullosa (DDEB).
Symptoms can vary widely among affected people. Individuals with DDEB typically have mild cases with blistering primarily affecting the hands, feet, knees, and elbows. RDEB cases can be painful and debilitating, often involving widespread blistering that can lead to vision loss, disfigurement, and other serious medical complications, which could be fatal.
Vyjuvek is a genetically modified (engineered in a laboratory) herpes-simplex virus used to deliver normal copies of the COL7A1 gene to the wounds. COL7 molecules arrange themselves into long, thin bundles that form anchoring fibrils that hold the epidermis (skin) and dermis together, which is essential for maintaining the integrity of the skin. Vyjuvek has also been modified to eliminate its ability to replicate in normal cells. Vyjuvek is mixed into an excipient (non-active ingredient) gel prior to topical application. A healthcare professional evenly applies Vyjuvek gel in droplets to a patient’s wounds once a week.
The safety and effectiveness of Vyjuvek was established primarily in a randomized, double-blinded, placebo-controlled study involving a total of 31 subjects with DEB, including 30 subjects with RDEB and one subject with DDEB. In the study, two DEB wounds of comparable size on each patient were identified and randomized to receive either topical administration of Vyjuvek or the placebo on a weekly basis. The age of the subjects ranged from 1 year to 44 years (mean age 17 years). Efficacy was established by improved wound healing, defined as the difference in the proportion of confirmed complete (100%) wound closure between the Vyjuvek-treated and the placebo-treated wounds at 24 weeks. Sixty-five percent of the Vyjuvek-treated wounds completely closed while only 26% of the placebo-treated wound completely closed.
In addition, in a different clinical study, two young patients with RDEB (6 and 7 months of age, respectively) received topical Vyjuvek weekly without any new safety findings.
The most common adverse reactions associated with Vyjuvek included itching, chills, redness, rash, cough and runny nose.
Patients or caregivers should take the following precautions during treatment with Vyjuvek:
- Avoid direct contact with treated wounds (e.g., touching and scratching) and dressings of treated wounds for approximately 24 hours following Vyjuvek application. In the event of accidental exposure, patients and exposed individuals should clean the affected area.
- Wash hands and wear protective gloves when changing wound dressings.
- Disinfect bandages from the first dressing change following Vyjuvek treatment with a virucidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or <0.4% ammonium chloride, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings and cleaning materials into a sealed plastic bag and dispose in household waste.
This application received Orphan Drug and Fast Track designations. Vyjuvek also received Regenerative Medicine Advanced Therapy and Priority Review designations and a Rare Pediatric Disease Priority Review Voucher. The FDA’s rare pediatric disease priority review voucher program is intended to encourage development of new drugs and biologics to prevent and/or treat rare diseases in children.
The approval of Vyjuvek was granted to Krystal Biotech, Inc.
Source: FDA
Author
Last Updated on May 6, 2026 by Daily News Staff
Second Nature Brands has issued a voluntary recall for certain 10-ounce pouches of SECOND NATURE KETO CRUNCH SMART MIX™ after discovering the product may contain undeclared cashews, pistachios, and cherries. For anyone with allergies or severe sensitivities—especially to tree nuts like cashews and pistachios—this is a serious safety issue.
The company says the affected product was distributed nationwide, both in retail stores and through online orders.
Why this matters
Undeclared allergens are one of the most urgent types of food safety alerts because consumers rely on labels to avoid ingredients that can trigger reactions. Second Nature Brands warns that people with allergies or severe sensitivity to cashews, pistachios, other tree nuts, or cherries could face serious or life-threatening allergic reactions if they consume the recalled product.
As of the announcement, no illnesses have been reported.
How to identify the recalled product
Check your pantry (and any recent online snack orders) for the following details:
- Product: SECOND NATURE KETO CRUNCH SMART MIX™
- Size: 10-ounce pouch
- UPC: 077034013405
- Best if used by date: 2/12/2027 (printed on the backside of the pouch)
Only pouches with the “Best if used by 2/12/2027” date are included. Other Best if used by dates are not affected, according to the company.
What happened
Second Nature Brands says the recall began after it was discovered that product containing cashews, pistachios, and cherries was placed into packaging that did not disclose those allergens. The company reports that a follow-up investigation indicates the issue was caused by a temporary breakdown in production and packaging processes.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
What consumers should do right now
If you have the affected product:
- Do not consume it.
- Keep the pouch (and take a photo of the UPC and Best if used by date if helpful).
- Contact Second Nature Brands for a full refund.
Contact information for refunds and questions
Second Nature Brands says consumers can reach them by phone or email:
- Phone: +1.800.651.7263
- Monday–Friday: 8:00 AM–8:00 PM ET
- Saturday–Sunday: 9:00 AM–5:00 PM ET
- Email: recall@secondnaturebrandsus.com
Health & fitness note: “Keto” doesn’t equal “risk-free”
Keto-friendly snacks can be convenient for people managing carbs, training schedules, or busy workdays—but this alert is a reminder that label accuracy is non-negotiable, especially for anyone balancing nutrition goals with medical dietary restrictions.
If you or someone in your household has a tree nut or cherry allergy, consider doing a quick sweep of:
- Snack drawers at home and work
- Gym bags and travel kits
- Recent bulk orders or subscription deliveries
Bottom line
If you have a 10-ounce pouch of SECOND NATURE KETO CRUNCH SMART MIX™ with UPC 077034013405 and Best if used by 2/12/2027, do not eat it. Contact Second Nature Brands for a refund and share the alert with anyone who may have purchased the product—especially those with tree nut or cherry allergies.
Source
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Health
Join the Fight Against ALS: Register and Make a Difference
Every year, doctors tell more than 5,000 Americans they have amyotrophic lateral sclerosis, better known as ALS. It is a life-changing diagnosis. In honor of ALS Awareness Month, learn more about the disease.
Join the Fight Against ALS: Register and Make a Difference
(Feature Impact) Every year, doctors tell more than 5,000 Americans they have amyotrophic lateral sclerosis, better known as ALS. It is a life-changing diagnosis.
Still, it’s hard to estimate the total number of ALS cases in the United States. No one knows what causes most cases of ALS, something the U.S. National ALS Registry is working to change.
In honor of ALS Awareness Month, learn more about the registry, how the information is used and how to enroll if you have ALS.
What is ALS?
ALS is a disease that affects the nerve cells that make muscles work in the body. This disease makes the nerve cells stop working and die. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak and leads to paralysis.
What is the registry?
“The National ALS Registry is a program of, by and for those living with ALS,” said Dr. Paul Mehta, principal investigator of the Registry. “The program collects, manages and analyzes data about people with ALS in the United States. It includes data and information provided by individuals who choose to register and complete the risk factor surveys.”
What is its purpose?
The main purpose is to gather information that can be used in the fight against ALS. The information is used to:
- Estimate the number of new cases of ALS diagnosed each year
- Estimate the number of people who have ALS at any given point in time
- Better understand who gets ALS and what factors affect the disease
- Enhance research that could improve care for people with ALS
How do researchers use the data?
Researchers can use the data to look for disease pattern changes over time and try to identify whether there are common risk factors among people with ALS. Since 2010, the registry has funded more than a dozen studies exploring potential ALS risk factors.
What does participation look like?
Individuals with ALS are encouraged to share their stories, enhancing ALS data and supporting research efforts. People living with ALS can help the National ALS Registry by completing up to 18 risk factor surveys, covering topics such as occupational history and environmental exposures, which help create a more complete picture of their ALS story.
How can someone join?
Anyone living with ALS can enroll. By joining and taking the risk factor surveys, individuals living with ALS can help future generations.
Get started at cdc.gov/als.
SOURCE:
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Lifestyle
Reclassification of marijuana opens doors for much‑needed medical research into the benefits and risks of the drug
The DOJ’s move to reclassify medical marijuana as Schedule III could unlock long-blocked cannabis research—while raising new questions about safety, regulation, and risk.
Carey S. Cadieux, Binghamton University, State University of New York
When the U.S. Department of Justice moved to reclassify medical marijuana to a Schedule III drug on April 23, 2026, it set the stage for a vast amount of medical research that has been hobbled for decades by its more restrictive Schedule I classification.
The Justice Department also called for an expedited federal rescheduling process, with proceedings expected to begin in late June 2026, but for now cannabis at the federal level remains a Schedule I drug.
I’m an associate professor of nursing and I edited a textbook for nurses about providing care with cannabis. Cannabis is the umbrella term for the plant genus that includes both marijuana and hemp – two varieties of the same plant distinguished primarily by their content of THC, one of the active components of cannabis.
Moving cannabis to a Schedule III drug ushers in the end of the cannabis prohibition era and the beginning of the regulation era, potentially creating promising opportunities around research and new therapeutics.
How are drugs regulated by ‘schedule’?
The Controlled Substances Act of 1970 categorizes all substances regulated under existing federal law into one of five schedules. The act regulates the manufacturing, importation, possession, use and distribution of substances on each schedule.
Several factors determine schedule placement, including the drug’s medical use, scientific evidence of its benefits and pharmacological effects, patterns and history of abuse, public health risk level, degree of physical or psychological addiction potential, and whether the drug can be used to make another controlled substance.
The Drug Enforcement Administration’s rescheduling of marijuana will move it from its current classification as a Schedule I drug, defined as having a high risk for abuse and no accepted medical use, to a Schedule III drug under the Controlled Substances Act. While still tightly regulated, Schedule III drugs are considered to have moderate to low risk for physical and psychological dependence and to have some medical benefits.
Other Schedule I drugs include heroin, psilocybin, LSD, peyote and MDMA, or ecstasy. These drugs cannot be dispensed or prescribed, with some exceptions. Current Schedule III drugs include ketamine, anabolic steroids, testosterone, products with less than 90 milligrams of codeine per dosage unit and some cannabinoids.
The move to reclassify medical marijuana products as Schedule III drugs applies only to those products certified by state-level medical cannabis programs. All other cannabis products remain a federal Schedule I drug, including those available from states’ recreational cannabis programs.
Impacts of cannabis reclassification
This legal order acknowledges that medical marijuana has some medical value and asserts that it has a lower potential for abuse than under the previous Schedule I classification.
The reclassification also ensures that state-registered medical cannabis patients continue to be permitted to purchase medical cannabis products without changes to their current certification or recommendation.
One of the challenges with this new law is that states have not standardized medical cannabis regulations, and each state will have its own quality and testing standards. In Maine, for instance, medical cannabis is not tested for molds, fungus, heavy metals or pesticides, while recreational cannabis is.
This means that the Schedule III medical cannabis in Maine could be contaminated, while the state’s testing of recreational cannabis makes it much safer to consume.
What are the implications for marijuana research?
For decades, researchers have struggled to conduct high-quality research studies due to their lack of access to the cannabis products that patients actually use and restrictions on their processes.
With the reclassification, researchers who are registered with the DEA to research cannabis will be able to obtain cannabis flower and plant material, as well as manufactured cannabis products, such as tinctures and edibles, directly from state-licensed businesses that are DEA-registered.
This means researchers will no longer need to rely on the federal DEA registry for access to cannabis products for research, which were often inferior in quality and variety in comparison to the everyday products medical cannabis patients typically have access to. Instead, they will be able to study cannabis products that patients use in daily life, such as vapes and various edible products.
This shift in access will now allow researchers to undertake the gold standard of research approaches: the randomized controlled trial.
Randomized controlled trials will help researchers like my colleagues determine how effective cannabis is in treating people with complex medical needs. This includes patients who experience nausea and pain while undergoing cancer treatments, multiple sclerosis patients with severe muscle spasm and stiffness, and chronic pain patients who strive to find relief without using opioids.
Might rescheduling send mixed signals?
Rescheduling may lead people to believe that cannabis is safe for all people to consume.
However, a growing body of research points to possible adverse effects from cannabis use, particularly in vulnerable groups, such as people who are pregnant, adolescents, people with preexisting mental health conditions such as schizophrenia or psychosis, and those with cardiac issues.
Cannabis can also lead to adverse drug interactions. Therefore, medical patients should use it with discretion and under the guidance of a healthcare professional.
For most medical cannabis patients, THC doses should start low and gradually be increased.
Rescheduling will be a big step toward helping researchers build a greatly needed solid body of evidence around both the benefits and potential harms of cannabis. But rescheduling should not be interpreted as a signal that cannabis is harmless.
Carey S. Cadieux, Associate Professor of Nursing, Binghamton University, State University of New York
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
