The FDA has approved an updated US label for ilunocitinib tablets (Zenrelia; Elanco), removing language about the risk of fatal vaccine-induced disease associated with the medication from modified live virus vaccines. The revision to the label comes after the federal agency reviewed additionally submitted data, according to an announcement by Elanco.

The immunosuppressant, first approved in September 2024, is a nonselective Janus kinase inhibitor administered once daily for the control of pruritus associated with allergic dermatitis and the control of atopic dermatitis in dogs of at least 12 months of age.

When the medication was first launched, the US label contained language based on lab study results in unvaccinated dogs given 3 times the approved dose of Zenrelia. According to Elanco, an outbreak of concurrent diseases occurred during the study, “complicating interpretation of the results.”

In the study, one treated dog developed fatal vaccine-induced adenoviral hepatitis and pancreatitis, and another developed infectious enteritis, according to the FDA's initial 2024 approval summary.

 Other dogs failed to mount an adequate response to rabies and distemper vaccines, as Zenrelia works partially by suppressing the immune system.

Still, in its initial approval last year, the FDA noted that “Zenrelia is safe and effective when used according to the label."

Having evaluated additionally submitted data, the FDA now states that “the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the labeling.”

However, a boxed warning on the label advising “discontinuation of Zenrelia for at least 28 days to 3 months prior to vaccination and withholding Zenrelia for at least 28 days after vaccination due to the risk of inadequate immune response to vaccines” still remains.

“When initiating treatment with Zenrelia, refer to label directions. Zenrelia should only be used in dogs that are up to date on vaccinations, at least 12 months old, and free from serious infection,” Elanco stated.

Dogs on Zenrelia should also be monitored for infections, as the medication increases the chances of developing an infection. During clinical studies, researchers observed benign and malignant neoplastic conditions in dogs. Common adverse effects associated with the medication include vomiting, diarrhea, and tiredness.

The medication has not been tested in breeding, pregnant, or lactating dogs, nor has it been evaluated in combination with other immunosuppressive therapies, such as glucocorticoids or cyclosporine.

"We appreciate the FDA's commitment to reviewing the latest submitted scientific data to ensure that the label is reflective of the totality of evidence," Ellen de Brabander, PhD, executive vice president of research, development, and regulatory affairs at Elanco, said in Elanco’s announcement.

In addition to the US, the drug has also become available in the European Union, Great Britain, Brazil, Canada, and Japan. According to Elanco, more than half a million dogs globally have been treated with Zenrelia.

Elanco announces FDA approves improved Zenrelia (ilunocitinib tablets) label, removing vaccine-induced disease language. News release. Elanco. September 23, 2025. Accessed September 23, 2025. 

https://www.prnewswire.com/news-releases/elanco-announces-fda-approves-improved-zenrelia-ilunocitinib-tablets-label-removing-vaccine-induced-disease-language-302564189.html

FDA approves new treatment for allergic skin conditions in dogs. News release. FDA. September 19, 2024. Accessed September 23, 2025. 

https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-new-treatment-allergic-skin-conditions-dogs

Articles

The revision removes language about fatal vaccine-induced disease from the skin allergy drug's label.

FDA approves updated US label for Zenrelia

Gallant, an animal health biotechnology company working on ready-to-use stem cell therapies for pets, announced the FDA’s Center for Veterinary Medicine (FDA-CVM) issued a complete letter for the Reasonable Expectation of Effectiveness technical section to support conditional approval of its ready-to-use stem cell therapy for refractory feline chronic gingivostomatitis (FCGS).

"This milestone represents a major leap forward in our mission to make stem cell therapies accessible to every pet in need," said Linda Black, DVM, PhD, CEO of Gallant, in an organizational release.

 "We're pioneering FDA-approved regenerative therapies designed to be practical and transformative—readily available, delivered through a simple intravenous injection, and aimed at treating the root cause rather than just the symptoms. We are entering the regenerative medicine era—and proud to be leading the way."

According to the release, the product under review is Gallant’s investigational new animal drug (INAD), sonruvetcel suspension for injection. This is potentially a first-in-class, uterine-derived allogeneic mesenchymal stromal cell therapy that is developed specifically for feline patients with refractory FCGs.

 Feline patients with refractory FCGS suffer from severe oral pain as well as a reduced quality of life, but there are currently no therapeutic options available. Because of this, many of these cats are then euthanized.

Gallant’s cells are sourced from a healthy, specific-pathogen free, FDA-qualified feline donors and then manufactured under current Good Manufacturing Practice conditions. Gallant disclosed that the conditional approval of the product is targeted for early 2026, and if given the conditional approval, this could be the first FDA-conditionally approved and ready to use stem cell therapy in veterinary medicine.

"Completion of the RXE technical section marks a foundational milestone for Gallant's uterine-derived platform of allogeneic mesenchymal stromal cell therapies—and the potential first ready-to-use stem cell therapy in veterinary medicine," said Valentine Williams, DVM, MS, DACVS (Equine), senior vice president of clinical development and strategy at Gallant, in the release.

"For many of us at Gallant, pioneering a gold-standard regenerative medicine platform has been a career-long ambition, serving beloved pets and enriching the lives of those who care for them. This success not only validates that vision but also demonstrates our ability to navigate the regulatory pathway for a pipeline of products that are leading the industry into the regenerative medicine era—an era focused on more than just managing clinical symptoms."

This therapy is in currently being reviewed for conditional approval and if granted, veterinarians will be able to begin prescribing and using the product in everyday practice for this ‘undeserved population of cats.’

In July of this year, Gallant raised $18 million in a Series B funding round to help develop and potentially commercialize its off the shelf stem cell therapies, including this one. Additional products in this new line of therapies include treatments for feline and canine osteoarthritis, canine atopic dermatitis, and feline chronic kidney disease, each of which will continue to be developed with funding.

A survey Gallant conducted with over 800 veterinarians in the US found that of those surveyed, 56% are satisfied with the current therapies out there for canine osteoarthritis, with most agreeing that current treatments focus on managing symptoms instead of addressing the underlying disease.

 Of those surveyed, only 8% showed satisfaction in the current treatments out there for FCGS. 

Gallant Achieves FDA "Technical Section Complete" for Reasonable Expectation of Effectiveness, Advancing First Ready-to-Use Stem Cell Therapy. News release. Gallant. September 23, 2025. Accessed September 23, 2025. https://prnmedia.prnewswire.com/news-releases/gallant-achieves-fda-technical-section-complete-for-reasonable-expectation-of-effectiveness-advancing-first-ready-to-use-stem-cell-therapy-302563870.html

2.Windsor R. Busting myths around stem cell therapy. DVM 360. Published July 31, 2025. Accessed September 23, 2025. https://www.dvm360.com/view/busting-myths-around-stem-cell-therapy

Bautista-Alejandre A. Veterinary stem cell therapy advances toward FDA approval with $18M in funding. dvm360. Published July 8, 2025. Accessed September 23, 2025. https://www.dvm360.com/view/veterinary-stem-cell-therapy-advances-toward-fda-approval-with-18m-in-funding

Veterinarians agree: Current treatments manage symptoms; anticipate regenerative options—Gallant study.

The agency found that Gallant’s data provides reasonable expectation of effectiveness. 

First ready to use stem cell therapy achieves FDA “technical section complete”

 My patients frequent emergency clinics for minor problems such as hot spots and torn dewclaws. Conversely, cats with dyspnea and dogs with heat stroke come through my general practice door too often. Why these venue mismatches? And how can I help my clients make better choices?

 For tiers of care, the offerings in the veterinary field have never been so vast. Not too long ago, the owner had one choice for their pet—their local general practitioner. These veterinarians were likely available 24-7, either in person or by phone after hours, and for anything from eyes to kidneys, topical treatment to emergency surgery. But today, the choices are jumbled.

“The options for triaging pets include general practice visits, urgent care visits during off-hours, emergency services, or telemedicine,” Michael Bailey, DVM, DACVR, president of the American Veterinary Medical Association (AVMA), said. When pets become sick or injured, he continued, clients are often uncertain where to seek care.

Erik Zager, DVM, DACVECC, head of emergency and critical care at Philadelphia Animal Specialty and Emergency in Pennsylvania, estimates that 20% to 25% of the cases that cross his threshold are not true emergencies and are better suited for their regular veterinarian. “They thought they saw a tick on their dog. Or their cat has been losing weight for 8 months,” he explained.

Urgent care centers are a nice step-down between emergency and general practice. They are for owners to use when the problem is 

, and their own vet is unavailable. They also scratch the itch of 

I don’t think it’s serious, but let’s make sure.

Zager said his emergency cases are frequently referred by nearby urgent cares. He estimates that he sees more second-hand cases from urgent cares or general practices that should have come directly to the emergency department than vice versa.

The pet owner’s first stop is not always the ideal one because most pet owners don’t have the medical background to triage their own pets, said Lenore Bacek, vice president of clinical affairs at Blue Pearl Specialty and Emergency Pet Hospital.

“I’m sure a lot of owners are confused between what an urgent care [facility] would do vs an emergency [team] vs their regular veterinarian,” she said. “But I would rather someone err on the side of caution and go to [the] emergency [department].”

Many owners are doing just this. According to Mordor Intelligence, the veterinary emergency care market is set to hit $20 billion for 2025, with North America taking the lead.

 Millennials and Gen Z populations drive pet adoptions and pursue emergency intervention more readily than their predecessors. Also, pet insurance penetration has grown recently, enabling owners to seek costly emergency and specialty care.

The AVMA lists 13 actual emergencies that warrant immediate veterinary care or consultation. These include seizures, fractures, eye injuries, breathing difficulty, and toxin exposure.

 Owners generally seem to have received the “memo.”

Investigators have found that accidental ingestions (toxins or foreign bodies) represent nearly one-third of the veterinary emergency care market last year, with respiratory distress cases on the rise.

For emergencies, must owners properly call the play? Zager said sometimes “emergency” is in the eye of the beholder. “My most experienced [emergency] doctor used to roll her eyes at every ear infection that came in, until her own dog got an ear infection that couldn’t wait until the morning,” he said.

Zager also said he thinks owners who are not “married” to a particular veterinarian in their usual hospital are more likely to head off to the emergency practice. “Sometimes they come into our emergency hospital because they want to hear better news than what they got from their regular vet,” he added.

Aime Berman, VMD, medical director at Dutton Road Veterinary Clinic in Philadelphia, Pennsylvania, said these second opinions, whether the problem is big or small, suggest a lack of trust between the client and their regular veterinarian.

But not always. Berman pointed out cases such as the suspectedintestinal foreign body that everyone is afraid to cut. The client cannot afford the recommended ultrasound to confirm the diagnosis and instead goes to an emergency care provider for a second opinion.

Nationwide Pet Insurance, which covers more than a million pets in the US, has identified 3 different pet owner personas based on how they select veterinary care. The first persona, explained Nationwide’s chief veterinary officer Emily Tincher, DVM, is care focused and prioritizes their pet’s health. They trust their own veterinarian but will go elsewhere if necessary.

The second is cost focused. Less likely to have a regular veterinarian, these owners access care when necessary and are unwilling or unable to pay a lot. The third persona is focused on convenience. These clients are busy and navigate care in ways that work for them.

So whether an owner overshoots or undershoots in their venue selection has much to do with their personality characteristics. “I think many people go to specialists for certain things that maybe a general practitioner can handle,” Berman said.

There are a few problems with this. First, emergency care is expensive. According to the pet health educational resource organization Preventive Vet, emergency care exams for dogs run from $96 to $236 and are slightly lower for cats.

 Emergency treatment for gastroenteritis and pancreatitis, which usually can be addressed at a regular clinic, can run into the thousands.

Anita McMillen, owner of Braden Run Animal Hospital in Waynesburg, Pennsylvania, recalls one of her patients, a 6-lb Yorkshire terrier, that ate some chewing gum. The animal’s owner rushed her to the local emergency practice, where her 4-day stay yielded some eyebrow-raising numbers: 8 veterinarians, 4 catheter changes, and an $8000 bill.

Speaking from her clinical experience, Tincher noted, “As you escalate up the level of care, the cost and the waiting times go up…. If I’ve got a hemoabdomen and a hit-by-car case, it might be hard for me to remember that the ear infection that’s here feels like an emergency to that owner.”

This is stressful for everyone and strains resources. Mary Jane McNamee, JD, VMD, co-owner of Apple Creek Veterinary Hospital in Lebanon, Pennsylvania, said her local emergency department has started to triage cases and send home those that are not true emergencies. “I appreciate that they are trying to break the cycle,” she said, “but really they have to focus their resources on those cases that are truly emergent.”

Nationwide’s Vet Helpline, a teletriage program offering 24-7 video consults with veterinary professionals, steers pet families to the right level of care when problems arise. This improves outcomes while balancing costs and other concerns, Tincher explained.

Human medicine has long embraced the concept of 

right care at the right time at the right place, 

which, Tincher explained, veterinary practices of all types can promote to their clientele in various ways. These include online billboards, TikTok videos, instructional voice mail messages, lobby art, and good verbal communication with owners.

“By providing clear, proactive guidance,” AVMA’s Bailey said, “the veterinary health team can improve efficiency; reduce stress for clients, pets, and staff; and ensure timely, appropriate care for their pets.”

Mordor Intelligence. Veterinary emergency care market size and share analysis-growth trends and forecasts (2025-2030). Accessed September 10, 2025. 2024. https://www.mordorintelligence.com/industry-reports/veterinary-emergency-care-market#:~:text=Veterinary%20Emergency%20Care%20Market%20Analysis,triage%20times%2C%20improving%20clinical%20outcomes

13 animal emergencies that require immediate veterinary consultation and/or care. American Veterinary Medical Association. Accessed September 10, 2025. https://www.avma.org/resources/pet-owners/emergencycare/13-animal-emergencies-require-immediate-veterinary-consultation-andor-care

Pet emergency statistics and veterinary costs. Preventive Vet. Accessed September 10, 2025. https://www.preventivevet.com/pet-emergency-statistics

Veterinary teams can help guide clients in understanding true emergencies vs conditions that general practitioners can manage.

Veterinary Vexations: The right place at the right time 

A case of New World screwworm (NWS) has been confirmed in Mexico less than 70 miles from the border with the US, according to an announcement by the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS).

 The case marks the northernmost detection of NWS amid the current outbreak, increasing concerns for the American cattle and livestock industry.

Mexico’s National Service of Agro-Alimentary Health, Safety, and Quality (SENASICA) detected the flesh-eating parasite on September 21 in Sabinas Hidalgo, Nuevo León. The city of Sabinas Hidalgo sits along a major highway from Monterrey, Nuevo León, to Laredo, Texas—one of the busiest trade routes in the world. On average, more than 18,500 trucks cross through the Laredo port every day, including more than 15,000 crossings through the World Trade Bridge.

In its announcement, the USDA called the most recent detection the “most threatening to the American cattle and livestock industry.”

US Secretary of Agriculture Brooke L. Rollins said the USDA is moving ahead with a 5-pronged plan to protect the US border from NWS. The plan includes investing in new eradication technologies, 

building sterile fly production and dispersal facilities in Texas

 increasing surveillance and detection efforts, increasing public awareness and education campaigns, and coordinating with Mexico and international partners to contain the parasite.

“USDA urges residents on the southern border to check their pets and livestock for signs of NWS,” the agency wrote in its announcement, encouraging pet caregivers and handlers to look for NWS signs in open wounds, body openings, genitalia, or the navel.

US Department of Health and Human Services authorizes emergency use of animal drugs for New World screwworm

“Look for draining or enlarging wounds and signs of discomfort. Also look for screwworm larvae (maggots) and eggs in or around body openings, such as the nose, ears, and genitalia or the navel of newborn animals. If you suspect your animal is infected with screwworm, contact your state animal health official or USDA area veterinarian immediately,” the USDA continued.

Before the most recent detection, the last northernmost case was confirmed in an 8-month-old cow on July 9, 2025, in Veracruz, which is located approximately 370 miles farther south. According to SENASICA, the affected animal had been recently moved to a certified feedlot in Nuevo León from a region in southern Mexico with active NWS cases.

As of now, US ports are closed to imports of cattle, bison, and horses from Mexico.

According to the USDA, the agency in collaboration with Mexico has been monitoring nearly 8000 traps throughout Texas, Arizona, and New Mexico, with more than 13,000 screening samples being submitted to date and no NWS flies detected.

“USDA is analyzing all new information related to the recent case in Nuevo León and will pursue all options to release sterile flies in this region as necessary,” the agency wrote.

Mexico Confirms Case of New World Screwworm in Nuevo Leon. US Department of Agriculture Animal and Plant Health Inspection Service. News release. September 21, 2025. Accessed September 22, 2025.

Economic Outlook Report. Laredo Chamber of Commerce. May 2024. Accessed September 22, 2025. 

https://laredochamber.com/wp-content/uploads/2024/10/202405-Vision.pdf?utm_source=chatgpt.com

Bautista-Alejandre A. Clinic center: USDA announces sterile fly facility at Texas base for screwworm eradication, and more. 

. July 9, 2025. Accessed September 22, 2025. 

https://www.dvm360.com/view/clinic-center-usda-announces-sterile-fly-facility-at-texas-base-for-screwworm-eradication-and-more

Bautista-Alejandre A. US Department of Health and Human Services authorizes emergency use of animal drugs for New World screwworm. 

. August 19, 2025. Accessed September 22, 2025. 

https://www.dvm360.com/view/us-department-of-health-and-human-services-authorizes-emergency-use-of-animal-drugs-for-new-world-screwworm

The case is the closest the parasite has come to the US during the current outbreak.

New World screwworm detected less than 70 miles from the US-Mexico border

Happy Monday dvm360 readers, and happy first day of Fall! A recent update has disclosed that there is a new reported case of New World Screwworm (NWS) closer to the US than it has been for the duration of this current outbreak. Our editorial team, along with host of dvm360’s Vet Watch Christopher Lee, DVM, MPH, DACVPM, will continue to cover the outbreak and provide updates. Be sure to continue checking in on dvm360.com and our social channels for the latest updates.

Here is what you can find this week on dvm360.com:

Mexico’s National Service of Argo-Alimentary Health, Safety, and Quality confirmed a new case of NWS less than 70 miles from the US-Mexico border in Sabinas Hidalgo, which is located in the state of Nuevo Leon. Currently, this latest case is the northernmost detection of NWS during the current outbreak.

Presidents from Iowa State University and Kanas State University recently traveled to Dublin, Ireland, last month to sign a memorandum of understanding to establish an academic exchange program to help foster research collaboration among the schools.

This week, we have a special treat for our Vet Blast Podcast listeners, we will have 2 podcasts launch! First, this Tuesday, Anthony Coronado, DVM, to discuss ways to help veterinary teams be more prepared for emergency medicine without having any panic. Then this Thursday, Zachary Neumann, MS, DVM, DACVIM (Oncology) and Dana Connell, DVM, MPH, MS, DACVIM (Oncology), join the show to talk more about the new era of canine cancer screening.

During an interview with dvm360 during our 2025 Fetch National Harbor conference, Kristi Fisher, CVT, VRCE, shares more on the difference between empathy and sympathy in the veterinary clinic, and how it can help teams connect with clients, especially during emergencies.

A recent study led by the University of Maryland that was published in 

 demonstrated promising results when a cat is infected with bird flu and gets early care and treatment.

Check out this week’s upcoming headlines on dvm360.com.

Sneak peek: New World Screwworm now within 70 miles of the US, and other news 

Officials with the FDA have approved an oral lincosamide antibiotic for canines. Clindamycin Hydrochloride Tablets (Felixvet Inc.) is indicated to treat skin infections, deep wounds and abscesses, dental infections and osteomyelitis caused by susceptible bacterial strains, according to the manufacturer. The drug has demonstrated activity against bacteria such as 

The newly approved therapy from Felixvet offers generic bioequivalence to Antirobe (Zoetis) clindamycin hydrochloride capsules. However, Felixvet’s product is manufactured in tablet dosage form, rather than capsule.

“With the approval of Clindamycin Hydrochloride Tablets, we’re expanding access to a trusted treatment option that veterinarians rely on for managing common yet potentially serious infections,” Vince Palasota, President of North America at Felixvet, said in a news release.

 “This product reflects our ongoing commitment to quality, affordability and clinical relevance.”

According to the FDA, bioequivalence was demonstrated in a study that compared the 150 mg Clindamycin Hydrochloride Tablets to the 150 mg Antirobe capsule. Thirty dogs between the ages of 6 months and 5 years were enrolled in the randomized, masked study.

“Clindamycin is an incredibly important anti-infective, or antimicrobial, for the management of multiple different infectious diseases and infectious conditions in pets,” Douglas Shane, DVM, PhD, veterinary director at Felixvet, said in a 

interview. “So, we're just going to continue to bring that Felix value to our vet clinics so that they have another partner for them, in their practices, they go [for] this widely used antimicrobial.”

Felixvet representatives noted that Clindamycin Hydrochloride Tablets is considered a “value-added generic,” which differs from a traditional generic product in that something has been changed. Palasota said creating a flavored chewable instead of recreating an unflavored chewable is an example of a value-added generic product. “We're taking the pioneer’s product, and we made some differentiation in the marketplace to try to do what we can do increase compliance with the pet or [provide] something different for the pet owner,” Palasota said in the interview.

“Clindamycin is a proven, versatile therapeutic, and we’re proud to add it to our growing portfolio,” Palasota added in the release.

 “We look forward to continuing to deliver solutions that meet the daily needs of veterinarians and their patients.”

Clindamycin Hydrochloride Tablets will be available only through a prescription. The product will be supplied as 25 mg tablets in 400-count bottles, 75 mg tablets in 200-count bottles, and 150 mg tablets in 100-count bottles.

Patients are dosed with Clindamycin Hydrochloride Tablets every 12 hours. The duration of treatment varies by infection type, typically a few days for acute infections and up to 28 days for osteomyelitis, according to Felixvet.

According to Felixvet, the company currently holds more than 20 FDA approvals and has a development pipeline with approximately 70 products in development, including 30 in stages along accelerated paths towards approval. “When you think of generic drugs in the animal health marketplace, there's only about 12% of the marketplace that has been genericized. So, there's a world of opportunities of new generics,” Palasota said in an interview with 

Felixvet receives FDA approval for Clindamycin Hydrochloride Tablets. News release. Felixvet. September 22, 2025.

Freedom of Information Summary: ANADA 200-813. FDA. June 27, 2025. Accessed September 22, 2025. 

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17171

Felixvet's Clindamycin Hydrochloride Tablets gain FDA approval, offering a new oral antibiotic option for treating various canine infections.