Shervin Assassi, MD, is the director of the division of rheumatology at McGovern Medical School, UTHealth Houston.

Nerandomilast Approval Expands Treatment Options for PPF, With Shervin Assassi, MD

The recent US Food and Drug Administration approval of Boehringer Ingelheim’s nerandomilast (Jascayd) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults marks a significant advancement for a disease that has historically had very limited treatment options.

The approval makes nerandomilast the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication and was based on results from the phase 3 FIBRONEERTM-ILD clinical trial, the largest clinical trial program in PPF to date.

“Until now, there was only 1 medication that is FDA approved for progressive pulmonary fibrosis,” Shervin Assassi, MD, director of the division of rheumatology at McGovern Medical School, UTHealth Houston, explained to 

. “Immunosuppressive agents are used for treating ILDs in certain settings, but until now, if those medications were not sufficient to control patients’ underlying ILD we didn't have any other options. Nerandomilast expands that armamentarium, and I think it's an excellent addition to our therapeutic options.”

The preferential PDE4B inhibitor’s approval in PPF was based on results from the phase 3 FIBRONEER-ILD clinical trial in which patients with idiopathic pulmonary fibrosis were randomly assigned in a 1:1:1 ratio to receive nerandomilast at a dose of 18 mg twice daily, nerandomilast at a dose of 9 mg twice daily, or placebo, with stratification according to background antifibrotic therapy with nintedanib or pirfenidone versus none. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at week 52.

Results showed nerandomilast demonstrated a significantly smaller reduction in FVC decline from baseline compared to placebo. The adjusted mean decline in absolute change from baseline in FVC in patients receiving nerandomilast 18 mg or 9 mg was -86 mL and -69 mL, respectively, versus -152 mL in the placebo group.

While there was no statistically significant difference for the key secondary composite endpoint of time to first acute ILD exacerbation, hospitalization for respiratory cause, or death, exploratory analyses suggested clinically meaningful trends. Nerandomilast 18 mg showed a nominally significant reduction in the risk of acute ILD exacerbations over the blinded trial duration compared to placebo (HR, 0.60; 95% CI, 0.38 to 0.94) as well as a numerical reduction in the risk of hospitalization for respiratory cause over the blinded trial duration compared to placebo (HR, 0.82; 95% CI, 0.61 to 1.11). An additional prespecified analysis of overall survival at the end of the FIBRONEER-ILD trial showed a trend in favor of nerandomilast.

“What is so important to keep in mind is that progressive pulmonary fibrosis is not just one diagnosis. There are multiple underlying diagnoses that lead to this similar downstream picture, which is basically pulmonary fibrosis,” Assassi told 

. “What was special here is that the results are consistent across all these diagnoses.”

He added that efficacy was observed across both treatment doses and regardless of background antifibrotic therapy, suggesting that nerandomilast could be used across different ILDs and may be particularly valuable for patients at high risk of progression.

Safety was another key component of nerandomilast and the FIBRONEER-ILD trial data that Assassi highlighted, noting similar rates of side effects and overall tolerability between the treatment and placebo groups.

“I think it's important to point out that the FIBRONEER-ILD trial is going after the concept that a scar is a scar, regardless of the divergent upstream diagnosis. Basically, once we have lung fibrosis, if you have an effective treatment, in this case, a preferential PDE4B inhibitor, that effective treatment will treat lung fibrosis regardless of what the upstream diagnosis is” Assassi said. “It brings rheumatology and pulmonary medicine together and helps us understand these diseases from a different perspective, but also encourages us to work together, which will ultimately benefit our patients in terms of longer survival and better quality of life.”

Editors’ Note: Assassi reports relevant disclosures with Boehringer Ingelheim, Janssen, Novartis, AbbVie, CSL Behring, and AstraZeneca.

Brooks A. FDA Approves Nerandomilast (Jascayd) Tablets for Progressive Pulmonary Fibrosis. HCPLive. December 19, 2025. Accessed December 22, 2025. 

https://www.hcplive.com/view/fda-approves-nerandomilast-jascayd-tablets-for-progressive-pulmonary-fibrosis

Richeldi L, Azuma A, Cottin V, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. doi:10.1056/NEJMoa2414108

Videos

Assassi reflects on the FDA approval of nerandomilast for progressive pulmonary fibrosis and the clinical benefits of the new PDE4B-targeted treatment option.

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Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Pulmonary Fibrosis

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Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: Orforglipron, Cagrilintide, and the Libre Assist

, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at the University Hospitals Diabetes and Metabolic Care Center, review major therapeutic and technology updates in diabetes care, beginning with newly announced topline phase 3 data for orforglipron, the first oral nonpeptide GLP-1 receptor agonist submitted to the 

00:00:15 Orforglipron and ATTAIN-MAINTAIN

00:07:33 Cagrelinitide with semaglutide at the FDA

Isaacs and Bellini first focus on the ATTAIN-MAINTAIN trial, which evaluated weight maintenance after patients transitioned from injectable incretin therapies to oral orforglipron. Bellini highlights that participants switching from semaglutide (Wegovy) maintained nearly all prior weight loss at 52 weeks, with an average regain of only 0.9 kg, while those transitioning from tirzepatide (Zepbound) experienced a modest regain of approximately 5 kg. A post hoc analysis further demonstrated substantial protection against weight regain compared with placebo, underscoring the potential role of oral GLP-1 therapy as a long-term maintenance strategy.

Isaacs and Bellini discuss the clinical implications of these findings, emphasizing patient preference, adherence, and real-world barriers to injectable therapies, such as travel, refrigeration, and injection fatigue. They note that an effective oral maintenance option—particularly one expected to be priced lower than injectable GLP-1 therapies—could significantly expand access and durability of weight loss, while still allowing flexibility to return to injectables if needed. The hosts also caution that weight regain may vary depending on prior therapy potency, reinforcing the need for individualized, shared decision-making.

The conversation then shifts to another major therapeutic milestone: the FDA submission of the amylin–GLP-1 combination cagrilintide plus semaglutide. Drawing on data from the REDEFINE trials, the hosts highlight weight reductions of up to 20% in individuals with overweight or 

, positioning this first-in-class combination as a potentially transformative option. They discuss the promise of expanded mechanisms of action, the possibility of improved tolerability profiles, and the broader trend toward increasingly potent incretin-based therapies, with several novel agents anticipated for approval in 2026.

In the latter part of the episode, Isaacs and Bellini turn to diabetes technology updates, spotlighting Abbott’s new Libre Assist feature, which integrates AI-powered food recognition into the Libre app. They describe how photo-based meal analysis provides real-time education on expected glycemic impact and practical dietary suggestions, framing it as a valuable tool for decision-making between clinic visits. They compare this approach with similar food-logging and glucose-response features available through Dexcom and third-party platforms, emphasizing the growing role of AI in personalized diabetes self-management.

The episode concludes with a discussion of expanded data-sharing capabilities for OmniPod 5 users on Libre systems, enabled through new cloud-to-cloud connections. The hosts stress the importance of CGM follow functionality for children, older adults, and individuals at risk for severe hypoglycemia or seizures, noting that these advances may reduce prior barriers to Libre adoption. Overall, the episode underscores rapid progress across therapeutics and technology, reinforcing a future of more flexible, patient-centered, and data-driven diabetes care.

Podcasts

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Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

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Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

FDA News

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The US Food and Drug Administration has approved Novo Nordisk’s once-daily semaglutide (Wegovy) pill, the first oral GLP-1 medicine for obesity in the US.

As described in a December 22, 2025, release from the Company, semaglutide pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. It is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.

"With more choices, HCPs are better equipped to tailor treatment approaches and support patients who want to gain control of their weight, and this milestone approval underscores exactly that kind of choice," Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham, said in a statement.

 "The availability of [semaglutide] pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery, allowing the ability to help meet more patients where they are."

On October 17, 2025, the Agency approved oral semaglutide 7 mg and 14 mg (Rybelsus) for cardiovascular (CV) risk reduction in patients with type 2 diabetes who are at high risk, irrespective of prior CV events. The decision made semaglutide the only oral GLP-1 medicine approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events.

The approval of oral semaglutide for obesity is based on results from the OASIS 4 phase 3 clinical trial, a 64-week medical study that included adults with obesity or overweight with ≥ 1 weight-related comorbidities, without diabetes. The trial included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.

A total of 307 participants were randomized in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks. For those taking semaglutide pill, 76% achieved ≥ 5% body weight loss from a baseline body weight of 235 lbs versus 31% taking placebo from a baseline body weight of 231 lbs.

Results showed that if all patients stayed on treatment, people taking semaglutide pill once-daily along with a reduced calorie diet and exercise achieved an average weight loss of about 17% (16.6%) versus about 3% (2.7%) with placebo. When looking at the efficacy regardless of if all patients stayed on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking semaglutiode pill compared to about 2% (2.4%) for placebo.

In OASIS 4, common adverse reactions were similar to those previously seen in clinical trials with semaglutide injection 2.4 mg, including nausea, diarrhea, and vomiting.

As described in the release from Novo Nordisk, the starting dose of 1.5 mg will be available in pharmacies and select telehealth providers in early January 2026 with savings offers for just $149 per month.

"After many years advocating for people living with obesity, one thing has always been clear: patient safety has to come first. That's why it's critical we rely on treatments that are rigorously tested and FDA-approved," said Joe Nadglowski, president and CEO of the Obesity Action Coalition.

 "A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1 treatment that can fit in their daily routine and preferences."

Novo Nordisk. FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults. December 22, 2025. Accessed December 22, 2025. 

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916473

Novo Nordisk. Novo Nordisk to present new data in oral semaglutide 25 mg (Wegovy® in a pill*) and obesity pipeline at ObesityWeek® 2025. October 20, 2025. Accessed December 22, 2025. 

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916436

Livingston R. FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes. HCPLive. October 20, 2025. Accessed December 22, 2025. 

https://www.hcplive.com/view/fda-approves-oral-semaglutide-rybelsus-for-cv-risk-reduction-in-type-2-diabetes

Articles

The FDA has approved Novo Nordisk's oral semaglutide (Wegovy) pill, the first oral GLP-1 medication for obesity in the US. This once-daily pill, combined with a reduced-calorie diet and increased physical activity, aids weight loss and reduces major adverse cardiovascular events in adults with obesity or overweight. The approval is based on the OASIS 4 phase 3 trial, which demonstrated significant weight loss in participants. Common adverse reactions include nausea and diarrhea. The pill will be available in early 2026, offering a new option for weight management.

The approval is based on the 64-week phase 3 OASIS 4 trial showing anaverage weight loss of ~17% if all patients stayed on treatment with semaglutide and ~14% regardless of if patients stayed on treatment.

FDA Approves Semaglutide (Wegovy) Pill As First Oral GLP-1 for Weight Loss

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A New Era in Food Allergy Treatment: The Push Toward Multi-Allergen Immunotherapy

Imagine avoiding your favorite coffee shop because the milk steaming in the air could trigger a severe allergic reaction. That was the reality for a patient of Ruchi Gupta, MD, until they began treatment with omalizumab (Xolair), the first biologic approved to target multiple food allergies. Today, the patient can enter the café freely with no reactions, no fear.

Omalizumab proved life-changing for the patient by targeting multiple food allergies in a single therapy.

“It’s not a cure, but it's increasing their thresholds to a point where they are not as worried, especially our most severely allergic patients and multi-allergic patients,” Gupta, a professor of pediatrics at Feinberg School of Medicine, Northwestern University, told 

. “You're seeing a real improvement in quality of life. I've seen really positive results with it.”

 approval of omalizumab in February 2024, allergists have continued to explore treatments for patients with multiple food allergies.

 The year 2025 marked a turning point in this space, bringing new research on oral immunotherapy (OIT), a head-to-head trial comparing omalizumab with OIT, and growing anticipation around upcoming studies of sublingual immunotherapy.

Food allergy prevalence has risen by 50% since the 1990s, according to the Centers for Disease Control and Prevention (CDC), with roughly 33 million people in the United States now living with food allergies.

 Experts point to several contributing factors, including the hygiene hypothesis, heightened awareness, shifts in the microbial environment, vitamin D levels, and rising caseation delivery rates.

Outdated guidance that once advised delaying the introduction of common allergens in young children may have also contributed.

The landmark LEAP trial, published in 2015, challenged this approach, demonstrating that early peanut introduction significantly reduced allergy risk. Supporting this shift, recent data suggest that 10 years after the American Academy of Pediatrics recommended early peanut introduction, peanut allergy rates declined by 27%.

Despite these advances, many infants continue to avoid common food allergens, coinciding with persistently high allergy prevalence. A 2024 FARE report found that approximately 40% of children with food allergies react to more than 1 food.

Food allergies can profoundly affect daily life, as fear of reactions, visible swelling, and dismissive attitudes from others can limit social interactions. These factors highlight the importance of therapies that address multiple food allergies, an area in which 2025 research has offered meaningful steps forward.

Multi-allergen oral immunotherapy has gained renewed attention with the investigational candidate ADP101.

“It's very exciting because we see almost over 50% really developing tolerance [with multi-food allergen OIT], so not just increasing your threshold, but potentially reversing it and allowing you to eat freely,” Gupta said. “[With] the biologic, we're still waiting to see if this could actually reverse it and allow you to eat freely or just to increase your threshold.”

ADP101, a novel, pharmaceutical-grade OIT, showed promise in the phase ½ Harmony trial for increasing the reactive threshold in children aged 4 - 17 years with single or multiple food allergies. This formulation contained equal amounts of allergenic proteins from 15 foods: almond, cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame, shrimp, soy, walnut, and wheat.

However, this study did not meet its primary endpoint, defined as the proportion of participants tolerating a ≥600 mg challenge dose without dose-limiting symptoms at week 40 during a double-blind, placebo-controlled food challenge (DBPCFC).

“I do think that it was just a very difficult study to do in the first place,” said Edwin Kim, MD, an investigator on the Harmony trial and a professor of allergy at the University of North Carolina at Chapel Hill, in an interview with 

. “As soon as you bring in multiple allergens, multiple variables, it gets harder and harder to meet the statistical significance that we're looking for. I do think…if we continue to treat for longer or [conduct a] larger study, we would see better results.”

Although this study missed its primary endpoint, the data showed that more than half of the participants (55%) receiving high-dose ADP101 (

 = .048) and 38.1% receiving low-dose ADP1010 (

 = .306) tolerated a ≥ 600 mg challenge dose, compared with 20% in the placebo group. After completing the exit DBPCFC, 68.8% on high-dose ADP101 (

 = .144) responded to treatment, compared to 23.5% on placebo.

For Kim, the most meaningful finding was the increase in allergen thresholds across multiple foods, reinforcing the broader applicability of OIT beyond peanut.

“It makes sense that the thresholds that we achieve for different foods may be slightly different, but I wouldn't expect them to be dramatically different,” Kim said. “To be able to see increased thresholds across several different unrelated foods was probably the most reassuring part of the study to me.”

ADP101 demonstrated a favorable safety profile, with most adverse events mild or moderate. Among the 61 participants, 75% on high-dose ADP101 and 76.2% on low-dose ADP101 experienced ≥ 1 treatment-emergent adverse event, compared with 60% of those receiving placebo.

According to ClinicalTrials.gov, the open-label extension of ADP101 was terminated due to a sponsor decision.

Even so, the pursuit of oral immunotherapy for multiple food allergies is far from over, and in many respects, it is not new.

Hugh Windom, MD, an allergist from Southgate, Florida, said he has treated patients with multiple food allergies in his clinical practice for years, long before the concept gained traction in clinical trials.

“I don't separate [multiple food allergy [from] single food allergy,” Windom told

“If the concept of oral immunotherapy works, which it does with 1 food, it's going to work with multiple foods. So, it really was never a gigantic leap to go from 1 to 2 to 3. Historically, we've been [giving] allergy shots for over 100 years, and we don't give [just cat or ragweed] allergy shots. We give multi-allergen shots every day of the week.”

He said that many clinics begin their patients with a single immunotherapy and later expand to additional allergens, referring to it as a natural progression. He also characterized the current landscape as the “wild west,” largely because of limited standardization beyond protein measurement.

“For many years, we were on the outside because there's no drug company behind us,” Windom said. “We won’t have the funds to adverse and to get FDA approval. We…needbuy-in from our national organizations to say, ‘Hey, this is standard of care.’”

He emphasized the importance of national organizations’ support. Allergies can be eliminated in children less than 5 years old, but children older than 5 will continue to have allergies and can only have symptoms lessened.

Future of Multiple Food Allergy Treatment: Sublingual Immunology

Windom also sees promise in sublingual immunotherapy for both single and multiple food allergies. In Europe, sublingual immunotherapy is commonly used for airborne allergens, such as ragweed and dust mite, often preferred over injections. In the United States, allergists have begun applying sublingual approaches for food allergies. The manufacturer of environmental sublingual tablets is also developing food-based products, including peanut formulations.

That said, many clinicians are not waiting for commercial products to reach the market. Instead, Windom said allergists often use real foods, much as they do with oral immunotherapy, placing substances such as peanut flour or milk under the tongue.

“It's a much safer, simpler, less expensive process,” he said. “It’s 4 visits, and you're on [a] top dose…you're gradually becoming desensitized.”

Significant questions persist, particularly regarding the expansion of sublingual immunotherapy beyond the more commonly studied foods, such as milk, egg, peanut, sesame, and certain tree nuts. Data are limited for grains and shellfish, as is the evidence around cross-protection.

“If I treat you with wheat, are you protected against rye or barley or some other grain?” Windom asked. “Could we treat you to shrimp, and would that protect you against other shellfish, lobster, crab? We need to learn more about cross-protection, so we don't need to treat you with 25 foods.”

It is already known that treating cashew covers pistachio and walnut covers pecan, but cross-protection between grains or shellfish remains less well studied.

Additional unanswered questions about multi-allergen immunology, including optimal treatment duration, how best to personalize therapy using genetics, the microbiome, or biomarkers, and whether emerging biologics, such as Bruton tyrosine kinase inhibitors, could expand multi-food protection. It is also unclear whether standardized multi-allergen OIT products will return or whether care will continue in a hybrid model combining clinic-based immunotherapy and biologics.

Looking Ahead in Multi-Allergen Immunology

Gupta noted that a sublingual epinephrine option may arrive as early as 2026. The FDA assigned Anaphylm, a sublingual film formulation of epinephrine, a Prescription Drug User Fee Act (PDUFA) date of January 31, 2026.

“With these new devices for treating allergy reactions, and then all the actual treatments to increase thresholds, I've seen a tremendous change, even in this year, but anticipate even more coming up because people will be able to access them and improve their quality of life,” Gupta said. “Plus, with prevention, with all the babies now eating allergens, maybe we'll be able to prevent this from the beginning and change the tide and actually decrease the incidence of food allergy from the very beginning.”

Gupta described a comic hanging up in her office. In 1 frame, an adult tells a child, “When I was your age, there were no food allergies.” In the other, the adult tells the child, “When I was your age, there were food allergies.”

“I don't know if we can change it in just a generation,” Gupta said. “The goal and the hope is, with all the amazing research happening around the world, that we'll see a big change happen in the next decade.”

Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. Hcplive. Published February 16, 2024. Accessed December 15, 2025. 

https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

Food Allergy Facts and Statistics for the U.S. Food Allergy Research & Education. Food Allergy Research & Education. Published April 18, 2024. Accessed December 15, 2025 

https://www.foodallergy.org/sites/default/files/2024-07/FARE%20Food%20Allergy%20Facts%20and%20Statistics_April2024.pdf

Derman C. Microbes, Medicine, Modern Life May Drive Food Allergy Rise, Experts Say. HCPLive. Published May 29, 2025. Accessed December 15, 2025. 

https://www.hcplive.com/view/microbes-medicine-modern-life-may-drive-food-allergy-rise-experts-say

Gabryszewski S, Gupta R, and Hernandez-Trujillo V. Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guidelines. HCPLive. Published Octber 30, 2025. Accessed December 15, 2025. 

https://www.hcplive.com/view/peanut-allergy-rates-plummet-10-years-aap-early-introduction-guidelines

Open-label Extension Study of ADP101. Clinicaltrials.gov. Published 2025. Accessed December 15, 2025. 

https://clinicaltrials.gov/study/NCT05243719

Brooks A. FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions. Hcplive.com. Published June 19, 2025. Accessed December 22, 2025. 

https://www.hcplive.com/view/fda-accepts-epinephrine-anaphylm-sublingual-film-nda-type-1-allergic-reactions

Omalizumab, the first biologic approved for multiple food allergies, has significantly improved patients' quality of life by increasing their allergen thresholds. Despite the rise in food allergy prevalence, recent advances in oral and sublingual immunotherapy offer promising treatment options. The investigational candidate ADP101 showed potential in increasing allergen thresholds, although it did not meet its primary endpoint. The future of food allergy treatment may include sublingual immunotherapy and emerging biologics, with ongoing research aiming to personalize therapy and explore cross-protection among allergens.

Innovative therapies and devices are transforming food allergy management, enhancing safety and quality of life for patients and families.

Food Allergy

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

This Year In Medicine

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

 and key trial results have punctuated 2025 for ophthalmology, making it a wildly productive year for the industry. Everything from diabetic retinopathy (DR) to 

 was addressed at some point, with crucial drugs like Susvimo and Acoltremon Ophthalmic Solution receiving approval to enter US markets. Treatment pipelines with Nanoscope and eSight also made significant progress this past year, as detailed in episodes of New Insight with Veeral Sheth, MD.

In light of the sheer number of news releases in 2025, the editorial team at 

 has summarized some of the most impactful headlines from throughout the year. Catch up on any bit-ticket stories you may have missed from 2025 below.


FDA Approves Susvimo for Diabetic Macular Edema


After this approval was announced on February 4, 2025, Susvimo, a ranibizumab-filled implant formerly known as the Port Delivery System with ranibizumab, became the first FDA-approved continuous delivery treatment for diabetic macular edema (DME). In addition to requiring fewer injections than standard therapy, Susvimo displayed continuous vision improvement in the phase 3 Pagoda study while remaining consistent with its known safety profile. During the trial, patients also received 4 loading doses of intravitreal ranibizumab prior to Susvimo implantation.


FDA Approves Revakinagene Taroretcel (ENCELTO) for MacTel


This March 6, 2025 approval marks the first ever FDA-approved treatment for macular telangiectasia type 2 (MacTel), a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss. Revakinagene taroretcel was designed to deliver continuous therapeutic dosses of ciliary neurotrophic factor to the retina via Neurotech’s encapsulated cell therapy technology. After implantation, the device’s semi-permeable exterior membrane allows nutrients to enter and proteins to travel to the retina.


FDA Approves Susvimo for Treatment of Diabetic Retinopathy


Another major Susvimo approval took place on May 22, 2025, marking it the first and only FDA-approved continuous delivery ttreatment capable of maintaining vision in patients with diabetic retinopathy (DR) – requiring only 1 refill every 9 months. The phase 3 Pavilion study highlighted Susvimo’s superiority to standard-of-care for DR, with roughly 80% of patients on Susvimo achieving a ≥2-step DR severity score improvement by week 100.


FDA Approves Acoltremon Ophthalmic Solution (TRYPTYR) for Dry Eye Disease


On May 28, 2025, the FDA’s approval of acoltremon ophthalmic solution for signs and symptoms of dry eye disease (DED) marked a significant turning point in treating one of the most common ocular surface disorders in the world. The decision was based on positive topline results from the COMET-2 and COMET-3 trials, which displayed acoltremon ophthalmic solution’s superiority to vehicle control. 42.6% of patients in COMET-2 achieved a ≥10 mm increase in unanesthetized Schirmer’s score compared to 8.2% receiving vehicle, and 53.2% of acoltremon patients versus 14.4% of vehicle patients achieved the same in COMET-3.


FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation


Announced on June 12, 2025, the FDA’s approval of prednisolone acetate ophthalmic suspension provides a new salvo against ocular inflammation, a notoriously difficult-to-treat condition due to physiological barriers such as frequent blinking and the tear film. Most commercial eyedrops also have low ocular bioavailability, requiring frequent doses; prednisolone acetate ophthalmic suspension, 1%, is a self-administered eye drop intended for use 2-4 times daily.


Intravitreal UBX1325 Shows Efficacy in Diabetic Retinopathy, DME, with Dante Pieramici, MD


The BEHOLD and ASPIRE trials have prominently displayed the safety and efficacy of UBX1325 (foselutoclax), an intravitreal injection targeting cellular senescence to slow the progression of DME and DR. The editorial team at 

 spoke with Dante Pieramici, MD, of the California Retina Research Foundation, to discuss the implications of this new gene therapy for common ocular diseases.


Lifitegrast 5% Improves All Biomarkers of Dry Eye Disease, Study Suggests


During a 12-week prospective observational case series study, lifitegrast displayed improvements in all measured clinical biomarkers of dry eye disease (DED) in adult patients. The antagonist of lymphocyte function-associated antigen-1 prevents inflammatory response by blocking this antigen from interacting with intercellular adhesion molecule 1. It also increases goblet cell number and area, as well as tear formation.


Veligrotug Shows Durability for Thyroid Eye Disease in Phase 3 Trial Results


The phase 3 THRIVE trial has highlighted veligrotug’s long-term durability in treating thyroid eye disease. These results came soon after the FDA granted Breakthrough Therapy Designation to the intravenously delivered anti-IGF-1R antibody. Veligrotug has the potential to be the intravitreal treatment of choice for active and chronic thyroid eye disease patients.


Faricimab Rapidly Reduces Retinal Fluid in nAMD in TENAYA and LUCERNE


A post-hoc analysis of the TENAYA and LUCERNE clinical trials highlighted faricimab as exhibiting greater improvements in anatomic outcomes versus aflibercept in patients with neovascular 

. In both trials, best-corrected visual acuity (BCVA) changes were substantially higher with faricimab compared to aflibercept, as well as effectively extending the time between treatments without sacrificing efficacy.


Faricimab Confirmed Safe for Treatment of Retinal Vein Occlusion


A secondary phase of the BALATON and COMINO trials met their primary endpoints of faricimab noninferiority to aflibercept at week 24, reaffirming faricimab’s efficacy in treating macular edema due to retinal vein occlusion. These sustained increases have not been seen in earlier central or hemiretinal retinal vein occlusion anti-VEGF trials – robust BCVA gains and CST reductions were maintained through all 72 weeks of the study.


New Insight: Restoring Sight With Nanoscope's MCO-010, With Ashish Patel, PhD, MBA


In this episode, host Veeral Sheth, MD, MBA, speaks with Ashish Patel, PhD, MBA, the senior vice president of sales and marketing at Nanoscope Therapeutics, Inc., to discuss the company’s current pipeline in therapeutic devices. The lead program, the MCO-010, is designed to deliver a broadband, highly sensitive opsin to bipolar cells, artificially converting them into surrogate photoreceptors and thereby restoring vision without requiring external goggles or light stimulation.


New Insight: The eSight Go with Roland Mattern, eSight Director of Marketing


In this episode, Sheth spoke with Roland Mattern to discuss the eSight Go, a fifth-generation wearable low-vision device built to enhance central vision function in patients suffering from macular degeneration, diabetic retinopathy, and Stargardt’s disease. Mattern details the history of the company, from its founding to its current pipeline, which aims to help patients with low vision regain mobility and independence.


New Insight: Exploring ENCELTO for MacTel with Rich Small, CEO of Neurotech


In this episode, Sheth spoke with Rich Small, the chief executive officer of Neurotech, about the FDA’s approval of revakinagene taroretcel-lwey for macular telangiectasia type 2. Small details the history of Neurotech, the scientific foundation of revakinagene taroretcel-lwey, and the ideal patient profile for this revolutionary medication. Small also indicated ENCELTO.com, a patient service hub aimed at streamlining diagnosis, treatment, and access to care for patients with macular telangiectasia type 2.


New Insight: A Deep Dive into the Oculis Pipeline with Riad Sherif, MD


In this episode, Sheth met with Riad Sherif, MD, the chief executive officer of Oculis, to discuss the company’s current treatment pipeline in ophthalmic therapeutics. The conversation highlighted OCS-05, a neuroprotective agent which has shown promising results in acute optic neuritis. At the time, the phase 2 ACUITY trial had just been presented, displaying OCS-05’s preservative effects on retinal ganglion cells, which in turn improved low-contrast visual acuity. Additionally, the majority of patients receiving OCS-05 experienced substantially fewer multiple sclerosis relapses, highlighting potentially broader neuroprotective potential.

The year 2025 was marked by significant advancements in ophthalmology, with numerous FDA approvals and key trial results. Notable approvals included Susvimo for diabetic macular edema and diabetic retinopathy, Revakinagene Taroretcel for macular telangiectasia type 2, and Acoltremon Ophthalmic Solution for dry eye disease. Trials such as BEHOLD, ASPIRE, and THRIVE demonstrated promising results for treatments targeting diabetic retinopathy, thyroid eye disease, and neovascular age-related macular degeneration. Additionally, podcasts and features highlighted innovative therapeutic devices and treatments, including Nanoscope's MCO-010 and eSight Go.

Catch up on the most impactful headlines in ophthalmology from all of 2025 with our Year in Review.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Age-Related Macular Degeneration

age-related macular degeneration condition center page is a comprehensive resource for clinical news and insights on retina disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for patients with AMD.

Diabetic Macular Edema

The HCPLive diabetic macular edema page is a comprehensive resource for clinical news and insights on DME. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the leading cause of blindness, and more.

Ophthalmology in 2025: Year in Review

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Catch up on some of the most significant headlines in atopic dermatitis news coverage from 2025 with our Year in Review.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Atopic Dermatitis in 2025: Year in Review

The FDA’s decision is based on positive results from the phase 3 THRIVE and THRIVE-2 clinical trials, which showed veligrotug’s efficacy and rapid onset of benefits.

FDA Accepts, Grants Priority Review to Veligrotug BLA for Thyroid Eye Disease

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

A multi-state cross-sectional analysis linked chronic kidney disease with increased COVID-19 hospitalizations, indicating more severe disease outcomes


Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

COVID-19

COVID-19 page, resources on the topics of medical news and expert insight into coronavirus can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COVID-19 research, treatment, and drug development.

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Ophthalmology in 2025: Year in Review