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.

Endocrinology has been on an upward track for most of 2025, and October has continued this trend. With crucial approvals from the 

 and key trial results for investigational new therapies, the industry is making great strides as we approach the end of the year.

The FDA’s approval of oral semaglutide 7 mg and 14 mg has revolutionized the already rapidly evolving GLP-1 field. Results from the DREAMS-3 trial have highlighted the superiority of mazdutide, a new GLP-1/glucagon dual receptor agonist, compared to semaglutide in 

. Inhaled insulin (Afrezza) from MannKind Corporation is moving towards approval with the FDA’s acceptance of its biologics license application for adolescents with 

With so many updates over the course of the month, the editorial team at 

 has collected 6 of the most important headlines from October. Check them out below.

FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes

On October 13, MannKind Corporation announced the FDA acceptance of their supplemental biologics license application for insulin human Inhalation Powder in children and adolescents with T1D or T2D. This application was supported by data from the phase 3 open-label INHALE-1 study, which saw the difference in mean HbA1c change between groups exceed the prespecified non-inferiority margin compared to daily injections of basal insulin. The FDA has assigned Afrezza a Prescription Drug User Fee Act target action date of May 29, 2026.

FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes

On October 17, the FDA approved semaglutide 7 mg and 14 mg for cardiovascular risk reduction in patients with T2D, irrespective of prior cardiovascular events. This groundbreaking decision marks the first approval of an oral GLP-1 receptor agonist, opening an entirely new pathway for treatment of both cardiovascular and obesity-related diseases.

Mazdutide Demonstrates Superiority to Semaglutide in Type 2 Diabetes and Obesity

Data from the DREAMS-3 trial has shown the superiority of mazdutide, Innovent Biologics, Inc.’s investigative GLP-1/glucagon dual receptor agonist, to semaglutide in patients with T2D and comorbid 

. Mazdutide afforded greater benefits in HbA1c and body weight reduction during the trial; coupled with its favorable safety profile, the drug has the capacity for applications in a range of other diseases and clinical fields.

FORWARD: Zimislecel Relieves Insulin Dependence in Patients with T1D with Michiel Nijhoff, MD

Zimislecel treatment during the FORWARD trial has led to meaningful continuous glucose monitor (CGM) metric improvements and reduced insulin dependence in patients with T1D, impaired hypoglycemic awareness, and severe hypoglycemic events. This investigative allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy may be capable of restoring a patient’s glucose regulating capabilities.

Adolescent Hyperglycemia in Type 1 Diabetes May Increase Adult Neuropathy Risk

Research from the University of Michigan Health has indicated that poor blood sugar control in children with T1D may be directly associated with increased risks of neuropathy in adulthood. Specifically, investigators noted a correlation between deviation from mean childhood HbA1c and increased neuropathy risk.

Normal Glucose Regulation May More Effectively Prevent T2D Than Weight Loss

In a post hoc analysis of the Prediabetes Lifestyle Intervention Study, investigators have demonstrated the achievability of prediabetes remission without gaining or losing weight. Additionally, prediabetes remission without weight loss may be protective from T2D development, as well as being associated with higher insulin sensitivity and improved insulin secretion.

Articles

Endocrinology has seen significant advancements in 2025, with notable FDA approvals and promising trial results. The FDA approved oral semaglutide for cardiovascular risk reduction in type 2 diabetes, marking a milestone in GLP-1 receptor agonist treatments. The DREAMS-3 trial demonstrated mazdutide's superiority over semaglutide in type 2 diabetes and obesity management. MannKind's inhaled insulin for pediatric diabetes is progressing towards approval. Research highlights include the link between adolescent hyperglycemia and adult neuropathy risk, and the potential of normal glucose regulation in preventing type 2 diabetes without weight loss.

Stay up to date with the groundbreaking FDA decisions, critical trial updates, and more news from the last month.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Type 2 Diabetes

Type 1 Diabetes

FDA News

6 Endocrinology Headlines You Missed in October 2025

Director of the NIHR Leeds Biomedical Research Centre; Prof of Musculoskeletal Medicine for University of Leeds, Honorary Consultant Rheumatologist for LTHT; NIHR Senior Investigator Emeritus

LEVI-04 Improves Pain, Function in Knee Osteoarthritis, with Philip Conaghan, MBBS, PhD

LEVI-04, a first-in-class p75 neurotrophin receptor-Fc fusion protein, has shown promising and clinically meaningful improvements in pain and physical function among patients with moderate-to-severe knee osteoarthritis (OA).

Findings from the multicenter, randomized, placebo-controlled phase 2 trial were presented by Philip Conaghan, MBBS, PhD, Director, NIHR Leeds Biomedical Research Centre, and Professor of Musculoskeletal Medicine at University of Leeds at the 

American College of Rheumatology (ACR) Convergence 2025

, held October 24–29 in Chicago, Illinois.

The trial enrolled 518 adults with radiographically confirmed (Kellgren-Lawrence grade ≥2) and symptomatic knee OA (≥4/10 WOMAC and ≥4/10 average weekly pain). Participants were randomized to receive intravenous placebo or LEVI-04 at doses of 0.3, 1.0, or 2.0 mg/kg at baseline and every 4 weeks through week 16. The primary endpoint was change in WOMAC pain at week 17, with additional assessments of WOMAC function, stiffness, patient global assessment (PGA), and average weekly numerical rating scale (NRS) pain.

Across all doses, LEVI-04 achieved statistically significant improvements in WOMAC pain versus placebo, with effect sizes that met or exceeded those typically reported for NSAIDs. Improvements increased with higher doses, underscoring a dose-response relationship. Clinical meaningfulness was further supported by results from the Staircase-Evoked Pain Procedure (StEPP), a standardized measure of pain on movement. A greater proportion of participants treated with LEVI-04 achieved the minimum clinically important difference (MCID) of 2 points in the StEPP versus placebo, with statistical significance observed in the 1.0 and 2.0 mg/kg groups.

Phase 3 studies are now being planned to confirm the efficacy and safety of LEVI-04 and further evaluate its long-term impact on pain and functional outcomes in knee OA. 

 spoke with Conaghan to learn more about LEVI-04 and its potential advantages for people with osteoarthritis.

"What we see that more people on LEVI-04 for all 3 doses achieved a clinically relevant reduction in that step function. So in other words, they were able to do more steps. Their pain related to steps was reduced, and that's really important for osteoarthritis, which is a disease where all the pain is related to how much you walk," Conaghan said.

Conaghan's disclosures include AbbVie/Abbott, Alfasigma, Eli Lilly, Eupraxia, Formation Bio, Galapagos, Genascence, Grunenthal, Janssen, Kolon TissueGene, Levicept, Medipost, Moebius Medical, Novartis, Orion, Pacira, Sandoz, Stryker, and Takeda.

Conaghan P, Katz N, Bihlet A, et al. LEVI-04, a Novel Neurotrophin-3 Inhibitor, Demonstrates Clinically Meaningful Improvements in Pain and Physical Function across a Range of OA Outcomes, Including the Staircase-Evoked Pain Procedure (StEPP). Presented at: ACR Convergence 2025; October 24-29; Chicago, Illinois. Poster #2101

Videos

Conaghan discussed the potential of LEVI-04 for knee osteoarthritis at ACR 2025.

Osteoarthritis

On the HCPLive osteoarthritis page, resources on the topics of medical news and expert insight into OA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on degenerative joint disease, and more.

Rheumatology

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.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Carla Marie Cuda, PhD, Solovy/Arthritis Research Society Research Professor of Medicine (Rheumatology) at Northwestern Feinberg School of Medicine

Revealing the Link Between Lupus Disease Activity and Cognition, With Carla Marie Cuda, PhD

Cognitive impairment, as measured on the National Institutes of Health Toolbox for Assessment of Neurological and Behavioral Function, correlated with Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores in new research that brings attention to quality of life issues in people with SLE.

, held October 24–29 in Chicago, Illinois, by Carla Marie Cuda, PhD, Solovy/Arthritis Research Society Research Professor of Medicine (Rheumatology) at Northwestern Feinberg School of Medicine.

Cuda and colleagues assessed 22 female patients with SLE free of concurrent autoimmune or neurologic disease with a mean age of 33.8 years (standard deviation [SD], 11.8) and disease duration of 8.9 years (SD, 6.0). They found that patients with moderate-high disease activity scored lower on the Dimensional Change Card Sort and Rey Auditory Verbal Learning Tests for executive function and delayed auditory-verbal memory, respectively, compared to those with inactive or low-moderate disease activity. Interestingly, low circulating complement C4 correlated with worse delayed auditory-verbal memory. The study validated the sensitivity of the NIHT as the clinically validated Montreal Cognitive Assessment (MoCA) did not reveal any differences between groups in the study.

 spoke with Cuda to learn more about the study and its findings. She shared some surprising observations made in the study that require further research, including hte link between circulating complement C4 correlated and auditory-verbal memory.

"I think the potential that, if you control [disease activity] that you can also improve someone's cognition would be very interesting, and especially if that then gets integrated into trials. A lot of these not-easily quantifiable symptoms are not being included necessarily for patients in clinical trials. So if that becomes a way in which to start to adjust for this and include patients and see if any of these drugs can actually impact cognition, would be amazing, and I think patients would want it, definitely," Cuda said.

Beiser S, Qureshi A, Safdar K, et al. Disease Activity Independently Correlates with Cognitive Impairment in Systemic Lupus Erythematosus.

Lupus

Lupus Disease Activity Correlates With Cognition, With Carla Marie Cuda, PhD

Credit: Northwestern Feinberg School of Medicine

, held October 24–29 in Chicago, Illinois, by Carla Marie Cuda, PhD, Solovy/Arthritis Research Society Research Professor of Medicine (Rheumatology) at Northwestern Feinberg School of Medicine. 

Cuda and colleagues assessed 22 female patients with SLE free of concurrent autoimmune or neurologic disease with a mean age of 33.8 years (standard deviation [SD], 11.8) and disease duration of 8.9 years (SD, 6.0). They found that patients with moderate-high disease activity scored lower on the Dimensional Change Card Sort and Rey Auditory Verbal Learning Tests for executive function and delayed auditory-verbal memory, respectively, compared to those with inactive or low-moderate disease activity. Notably, low circulating complement C4 correlated with worse delayed auditory-verbal memory. 

 spoke with Cuda to learn more about the rationale for the study and the potential of the NIHT to help measure cognitive impairment.

Can you give some background on this research and why you chose to look at mild cognitive impairment and disease activity in SLE?

So I have done most of my work in animals, but we were looking for a way to translate the work I've been been doing in that space into more patient oriented work at our translational program. So we are tapping into what I feel is really an underserved space of a spectrum of neuropsychiatric manifestations that occur and that there's plenty of others as well, but I feel like mild cognitive impairment is very difficult to diagnose, there aren't a lot of tools in order to assess that.

Current ways to assess cognition in the clinic space require for a physician to refer them to neuropsychological testing, but patients aren't often going to be pushed to that unless there's very overt signs that that type of assessment is required but that leaves behind then several categories that they are not getting visits for what I feel is a very important part of someone's daily life, and that really directly contributes to their quality of life. 

So what we had decided to do was with my cellular immunology background and in conjunction with a neuroimmunologist and neuropsychologist, several rheumatology clinicians, we developed this infrastructure in Northwestern where patients and do our study, we get a number of patient report outcomes: fatigue  pain interference, sleep disturbances, just to name a few, and then patients will also undergo cognitive assessments using the NIHT and then we also add blood serum, peripheral mononuclear cells, and then a fraction of patients we will get cerebrospinal fluid from as well. 

What advantages does the NIHT offer for assessing cognitive impairment in the study?

At our research institution, we have really esteemed researchers in the neuro realm, looking at long COVID and this NIH toolbox was being used and implemented in this way, and so we tried to capitalize on that, because other people at the university are utilizing this interactive platform. It's easily taken on an iPad and patients will undergo a composite of 5 tests that will signify certain domains of cognitions, processing speed, executive function, and then they also do an assessment of auditory verbal learning, as well as delayed recall of that. So those things just a nice, broad spectrum of domain testing to see if there's particular difficulties that will correspond to either clinical data, patient reported outcomes, and data that we can glean from the cells and fluids that we're collecting in our analyses.

This transcript has been edited for clarity.

Beiser S, Qureshi A, Safdar K, et al. Disease Activity Independently Correlates with Cognitive Impairment in Systemic Lupus Erythematosus. 

Research highlights a correlation between cognitive impairment and disease activity in Systemic Lupus Erythematosus (SLE), emphasizing quality of life concerns. Presented at the ACR Convergence 2025, the study involved 22 female SLE patients, revealing that moderate-high disease activity is linked to poorer executive function and memory. Low complement C4 levels were associated with worse memory outcomes. The NIH Toolbox (NIHT) was utilized for cognitive assessment, offering a comprehensive evaluation of cognitive domains. This approach aims to address the underdiagnosed cognitive impairments in SLE, enhancing patient care and quality of life.

New research at ACR 2025 highlights the link between cognitive impairment and disease activity in SLE.

Unseen Symptoms: Cognitive Decline Reveals Quality-of-Life Impacts of SLE, with Carla Cuda, PhD

Anita Afzali, MD, is a gastroenterologist and professor of clinical medicine at the University of Cincinnati.

Guselkumab Shows Improved Outcomes in Crohn’s Disease: Insights From GALAXI Trial, With Anita Afzali, MD

Recent findings from 2 post hoc subgroup analyses of GALAXI phase 2b and 3 trial highlight guselkumab’s improved clinical and endoscopic outcomes in treating patients with moderately to severely active Crohn’s disease (CD).

The data was presented in dual abstracts at the 

 (ACG)’s 2025 Annual Scientific Meeting by Anita Afzali, MD, MPH, Professor of Clinical Executive Vice Chair, Internal Medicine at the University of Cincinnati, who offered insights into the evolving landscape of inflammatory bowel disease and its effective treatments. The promising clinical effects of guselkumab, a dual-acting IL-23 antagonist and P19 inhibitor, have been proven in patients with moderately to severely active CD, defined as Crohn’s Disease Activity Index (CDAI) 220-450 and a mean daily stool frequency (SF) score >3 or AP score >1.

In September 2025, the US Food and Drug Administration (FDA) approved 

, making it the first IL-23 inhibitor with a dual subcutaneous and intravenous induction option for the treatment of ulcerative colitis and CD. The randomized double-blind, placebo-controlled, parallel-group, multicenter, treat-through phase 3 study, ASTRO, showed early symptomatic response improvements in guselkumab-treated patients as early as 2 weeks into the trial and sustained through week 24.

Further analysis of GALAXI 2 & 3 phase 3 treat-through studies strived to determine whether increased maintenance doses would improve results in patients with greater inflammatory burden and disease severity at baseline. The clinical outcomes of clinical remission, a CDAI < 150, and endoscopic response, ≥50% improvement in simple endoscopic score (SES-CD) or SES-CD≤2, were compared in a randomly-assigned dosing of subcutaneous 100mg q84 versus 200mg q4w. Those with high disease activity at baseline, defined as CDAI >300 or SES-CD >12, greater inflammatory burden after induction, or who had not achieved an endoscopic response after induction, saw a greater clinical and endoscopic outcome when introduced to the higher dose of 200 mg q4w.

“If there was a higher burden of inflammation, a higher baseline CDAI score, a higher SCS CD score, or the patient did not have an endoscopic response or a CRP response after induction doses, patients were more likely to achieve better outcomes if they were on the higher maintenance dose,” Afzali said in an interview with 

. “This was a great post hoc to help us determine what we do when it comes to maintenance dosing. And I think for my actual clinical practice, I'm going to go straight to that 200 milligrams every 4 weeks because we have patients who have a high level of inflammatory burden, and these are the patients we want to get it right.”

Additional data from the phase 2b and 3 studies showed clinical improvement in 80 patients who were non-responsive to treatment by ustekinumab 90mg SC q8w when switched to 200 mg guselkumab q4w without IV induction. Investigators collected patient data 16 weeks after treatment, showing that more than 50% had achieved clinical remission. In a year, follow-up, 96 weeks after the treatment switch, 50% of patients achieved an endoscopic response.

“So among these patients, without an induction, they were able to have efficacy, and we did not see any other safety concerns either. I think this really helps us when we talk about not just positioning, but also sequencing of therapies,” concluded Afzali. “A very common question I'm asked is, ‘Well, if my patient was previously on ustekinumab, may I or should I or could I still consider guselkumab?’ And this subgroup analysis offers a ‘yes’ to us for the right patient to determine that maybe this is an option for that right individual.”

Editor's note: Afzali reports relevant disclosures with AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Johnson & Johnson, Takeda, and others.

Afzali A, Wolf D, Leong R, Van Rampelbergh R. Efficacy and Safety of Subcutaneous Guselkumab Rescue ... : Official journal of the American College of Gastroenterology | ACG. 

https://doi.org/10.14309/01.ajg.0001133276.53761.51

Alzali A, Hisamatsu T, Rubin D. S1452 Guselkumab Maintenance Dose Regimens in Patients With ... : Official journal of the American College of Gastroenterology | ACG. 

https://doi.org/10.14309/01.ajg.0001133268.32992.d0

Afzali details GALAXI post hoc findings on guselkumab in Crohn’s disease.


Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Guselkumab Shows Improved Outcomes in Crohn’s Disease: Insights From GALAXI, With Anita Afzali, MD

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.

This month in review spotlights 6 top allergy stories, from falling peanut allergy rates to intranasal steroid cream easing post-surgical rhinosinusitis.

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.

Food Allergy

6 Allergy Headlines You Missed in October 2025

Silvana Bonilla, MD, Attending physician, Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA; Harvard Medical School, Boston, MA. 

A multicenter study from NASPGHAN 2025 highlights geographic and immune-driven variations in pediatric H. pylori infection across the Americas.

Silvana Bonilla, MD, Explores Geographic Patterns of H. Pylori in Pediatric Digestive Disease

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.

Check out the latest GI FDA news, new trial data in IBD, headlines from ACG 2025, and more.

6 Gastroenterology Headlines You Missed in October 2025

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.

October brings FDA approvals, new KDIGO guidance, and diagnostic breakthroughs

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.

5 Nephrology Headlines You Missed in October 2025

Based on results from the THRIVE and THRIVE-2 phase 3 studies, this Biologics License Application includes a request for Priority 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.

Thyroid Disorders

Viridian Therapeutics Announces Submission of BLA for Veligrotug in Thyroid Eye Disease

Translational medicine expert at the University of Leeds

Phase 2 trial shows ianalumab achieves sustained lupus disease control, supports steroid tapering, and increases time in remission over 1 year.

Ianalumab Provides Clinical Benefit in Lupus Phase 2 Trial, With Ed Vital, MD

Catch up with groundbreaking FDA decisions, exciting new GLP-1 news, and more.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Cardiomyopathy

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Atherosclerotic Cardiovascular Disease

8 Cardiology Headlines You Missed in October 2025

Phase 3 data show dapirolizumab pegol improved remission and disease stability in lupus; a second trial and patient-reported outcomes are now underway.

What’s Next for Dapirolizumab Pegol Following Lupus Phase 3 Trial, With Ed Vital, MD

Check out the latest episode of Liver Lineup on alcohol-associated liver disease, new data on resmetirom, hepatic headlines from ACG 2025, and more.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

6 Hepatology Headlines You Missed in October 2025

At ACR 2025, Vital discussed phase 3 data showing dapirolizumab pegol improved remission and stabilized disease activity in patients with lupus.

Latest News

6 Endocrinology Headlines You Missed in October 2025

LEVI-04 Improves Pain, Function in Knee Osteoarthritis, with Philip Conaghan, MBBS, PhD

Lupus Disease Activity Correlates With Cognition, With Carla Marie Cuda, PhD

Unseen Symptoms: Cognitive Decline Reveals Quality-of-Life Impacts of SLE, with Carla Cuda, PhD

Guselkumab Shows Improved Outcomes in Crohn’s Disease: Insights From GALAXI, With Anita Afzali, MD