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.

 has granted 510(k) clearance to Theracor, the first human umbilical cord–derived medical device offered in a sheet formulation, according to an announcement from StimLabs on December 29, 2025.

“Receiving 510(k) clearance for Theracor underscores our leadership and offers greater options to clinicians and patients who benefit from human tissue-based solutions for the management of acute and chronic wounds,” said John Daniel, founder and chief executive officer of StimLabs, in a statement.

The clearance is an expansion upon the FDA’s prior authorization of Corplex P, the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format. Unlike particulate formulations, the sheet format is designed for clinicians who require a continuous wound coverage option with a comparable human tissue-based medical device. The sheet formulation offers an alternative delivery format for these clinicians, according to the statement from StimLabs.

Theracor is derived from human umbilical cord extracellular matrix (ECM) and is intended to cover and protect wounds while maintaining a moist wound environment. The device is indicated for the same wound types as Corplex P, including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled and undermined wounds, surgical wounds including donor sites, grafts, post-Mohs surgery, and wound dehiscence, trauma wounds, partial-thickness burns, skin tears, and draining wounds.

According to the company, the clearance reflects the continued expansion of FDA-cleared umbilical cord–derived medical devices intended for use in complex wound management settings.

“By expanding our product portfolio, we empower clinicians with choice and strengthen our commitment to innovating around unmet clinical needs while meeting the highest standards," stated John Daniel. "With Corplex P already FDA cleared and available nationwide, Theracor rounds out our offering, arming wound care providers with an expanded suite of human umbilical-cord derived devices."

StimLabs. StimLabs® Announces FDA Clearance of TheracorTM: The First Human Umbilical Cord-Derived Medical Device Sheet. Prnewswire.com. Published December 29, 2025. Accessed December 29, 2025. 

https://www.prnewswire.com/news-releases/stimlabs-announces-fda-clearance-of-theracor-the-first-human-umbilical-cord-derived-medical-device-sheet-302649759.html

FDA Clears Groundbreaking Corplex-PTM: The First Human Umbilical Cord-Derived Medical Device Corplex-P. StimLabs. 

https://stimlabs.com/Corplex-P_Press_Release/

Articles

The FDA has granted 510(k) clearance to Theracor, a human umbilical cord-derived medical device in sheet form, developed by StimLabs. This clearance expands upon the previous authorization of Corplex P, a particulate format device. Theracor provides continuous wound coverage and is intended for various wound types, including ulcers, burns, and surgical wounds. The clearance signifies the growing acceptance of umbilical cord-derived devices in complex wound management. StimLabs aims to offer clinicians more options and address unmet clinical needs with their expanded product portfolio.

FDA clears first human umbilical cord–derived sheet device, Theracor, for wound Care


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.

FDA News

FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

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.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

The Skin of Color Savvy podcast, presented by Skin of Color Society (SOCS) leaders and produced by HCPLive, presents a special year-end highlights reel to close out 2025, featuring moments from every 'Savvy Conversations' episode released throughout 2025. The compilation reflects the breadth of topics, voices, and lived experiences that shaped the podcast’s inaugural year, underscoring its commitment to advancing clinically rigorous, culturally responsive dermatologic care for patients of color.  Throughout the season, expert dermatologists explored conditions that disproportionately affect patients with skin of color, including atopic dermatitis, prurigo nodularis, vitiligo, pigmentary disorders, hidradenitis suppurativa, scarring alopecia, and curly hair–specific concerns. In conversations featuring Andrew Alexis, MD, MPH, and Shawn Kwatra, MD, the discussion centered on the biologic and social drivers of itch and inflammatory skin disease, highlighting how environmental exposures and health disparities intersect with cutaneous health.  Pigmentary disorders were a recurring theme, with episodes featuring Nada Elbuluk, MD, MSc, Michelle Rodrigues, MBBS, Esther Freeman, MD, PhD, and Karolyn Wanat, MD, emphasizing the diagnostic complexity of hyperpigmentation, hypopigmentation, and depigmentation across diverse skin types. These conversations reinforced the importance of nuanced clinical evaluation and patient-centered decision-making, particularly when conditions such as vitiligo are incorrectly dismissed as cosmetic.  Hair and scalp disorders were another focal point of the season. Episodes with Crystal Aguh, MD, John Harris, MD, PhD, Loren Krueger, MD, Victoria Barbosa, MD, MPH, MBA, Janiene Luke, MD, Amy McMichael, MD, and Kayla Taylor, MD, addressed scarring and non-scarring alopecias, the role of hair-care practices, and the cultural significance of curly and textured hair. Panelists stressed that hair loss often requires time-intensive visits, longitudinal care, and open conversations about styling, identity, and patient expectations.  Patient perspective was powerfully incorporated during the episode featuring Tiffany Mayo, MD, Steven Daveluy, MD, and patient advocate Jasmine Ivanna Espy, who shared her lived experience with hidradenitis suppurativa. Her story highlighted the diagnostic delays, emotional burden, and quality-of-life impact of chronic inflammatory disease, reinforcing the importance of listening to patients as partners in care.  Additional episodes tackled sunscreen counseling, winter skin care, and the need for diversity in clinical trials, with insights from Rebecca Vasquez, MD, Adewole Adamson, MD, MPP, Raj Chovatiya, MD, PhD, and Tasneem Mohammad, MD, alongside discussions on global dermatologic equity and the expanding role of organizations like the Skin of Color Society.  Together, the year-end reel captures the essence of Skin of Color Savvy: a platform grounded in evidence-based medicine, cultural humility, and inclusive dialogue. As the podcast looks ahead to the coming year, the highlights serve as a reminder of the progress made, and the work still needed, to improve dermatologic care for all patients.  To learn more about SOCS’s mentorship programs and initiatives, visit Skin of Color Society.  Editor’s note: This summary was edited with the help of artificial intelligence tools.

, presents a special year-end highlights reel to close out 2025, featuring moments from every 'Savvy Conversations' episode released throughout 2025. The compilation reflects the breadth of topics, voices, and lived experiences that shaped the podcast’s inaugural year, underscoring its commitment to advancing clinically rigorous, culturally responsive dermatologic care for patients of color.

Throughout the season, expert dermatologists explored conditions that disproportionately affect patients with skin of color, including atopic dermatitis, prurigo nodularis, vitiligo, pigmentary disorders, hidradenitis suppurativa, scarring alopecia, and curly hair–specific concerns. In conversations featuring Andrew Alexis, MD, MPH, and Shawn Kwatra, MD, the discussion centered on the biologic and social drivers of itch and inflammatory skin disease, highlighting how environmental exposures and health disparities intersect with cutaneous health.

Pigmentary disorders were a recurring theme, with episodes featuring Nada Elbuluk, MD, MSc, Michelle Rodrigues, MBBS, Esther Freeman, MD, PhD, and Karolyn Wanat, MD, emphasizing the diagnostic complexity of hyperpigmentation, hypopigmentation, and depigmentation across diverse skin types. These conversations reinforced the importance of nuanced clinical evaluation and patient-centered decision-making, particularly when conditions such as vitiligo are incorrectly dismissed as cosmetic.

Hair and scalp disorders were another focal point of the season. Episodes with Crystal Aguh, MD, John Harris, MD, PhD, Loren Krueger, MD, Victoria Barbosa, MD, MPH, MBA, Janiene Luke, MD, Amy McMichael, MD, and Kayla Taylor, MD, addressed scarring and non-scarring alopecias, the role of hair-care practices, and the cultural significance of curly and textured hair. Panelists stressed that hair loss often requires time-intensive visits, longitudinal care, and open conversations about styling, identity, and patient expectations.

Patient perspective was powerfully incorporated during the episode featuring Tiffany Mayo, MD, Steven Daveluy, MD, and patient advocate Jasmine Ivanna Espy, who shared her lived experience with hidradenitis suppurativa. Her story highlighted the diagnostic delays, emotional burden, and quality-of-life impact of chronic inflammatory disease, reinforcing the importance of listening to patients as partners in care.

Additional episodes tackled sunscreen counseling, winter skin care, and the need for diversity in clinical trials, with insights from Rebecca Vasquez, MD, Adewole Adamson, MD, MPP, Raj Chovatiya, MD, PhD, and Tasneem Mohammad, MD, alongside discussions on global dermatologic equity and the expanding role of organizations like the Skin of Color Society.

Together, the year-end reel captures the essence of 

: a platform grounded in evidence-based medicine, cultural humility, and inclusive dialogue. As the podcast looks ahead to the coming year, the highlights serve as a reminder of the progress made, and the work still needed, to improve dermatologic care for all patients.

To learn more about SOCS’s mentorship programs and initiatives, visit 

Editor’s note: This summary was edited with the help of artificial intelligence tools.

Videos

In this end-of-year reel, HCPLive has showcased several key highlights from the Skin of Color Savvy podcast in 2025.

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Podcasts

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

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.

Skin of Color Savvy: Highlights from 2025

Announced on December 29, 2025, by Praxis Precision Medicines Inc.,

 the US Food and Drug Administration (FDA)

 has granted Breakthrough Therapy Designation for ulixacaltamine for the treatment of patients with essential tremor.

“The granting of the Breakthrough Therapy Designation for ulixacaltamide, based on the Essential3 program, further underscores its potential to address the substantial unmet need in patients with ET,” said Marcio Souza, president and chief executive officer, in a statement. “We recently completed a series of positive interactions with the FDA, that, together with this BTD, are enabling us to advance this promising treatment faster to patients. We are diligently preparing for the filing of the ulixacaltamide NDA, which we expect in early 2026.”

The most common movement disorder globally, essential tremor, affects an estimated 7 million individuals in the United States. Propranolol, a beta-blocker, remains the only pharmacotherapy previously approved for ET. Ulixacaltamide is a differentiated, highly selective small-molecule inhibitor of T-type calcium channels designed to block abnormal neuronal burst firing in the cerebello-thalamo-cortical circuit associated with tremor activity, with the potential to expand treatment modalities.

The FDA decision was supported by positive topline data from the phase 3 Essential3 program, which consisted of 2 simultaneously enrolled studies using a decentralized design conducted in the United States. Across the program, participants were allocated in a 2:1 blinded randomization.

Study 1 was a double-blind, parallel-group, placebo-controlled trial in which patients were randomized 1:1 to receive either ulixacaltamide or placebo for 12 weeks. The primary endpoint was the change from baseline in the modified Activities of Daily Living 11-item scale (mADL11) at Week 8.

Study 2 was a stable-responder randomized withdrawal study in which participants received ulixacaltamide for 8 weeks. Patients who achieved a ≥3-point improvement from baseline in mADL11 were then randomized to placebo or continued ulixacaltamide for an additional 4 weeks. The primary endpoint assessed the proportion of patients who maintained response with ulixacaltamide compared with placebo.

Across both studies, key secondary endpoints included the rate of disease improvement, defined as the slope of mADL11 change, Patient Global Impression of Change (PGI-C), and Clinical Global Impression of Severity (CGI-S).

Study 1 included 473 patients, and study 2 enrolled 238 patients with essential tremor.

In Study 1, ulixacaltamide demonstrated a statistically significant and clinically meaningful 4.3-point mean improvement in mADL11 at Week 8 (

 <.0001). Treatment effects were observed as early as Week 2 and sustained through the 12-week dosing period. All key secondary endpoints achieved statistical significance.

In Study 2, among patients meeting responder criteria, 55% of those receiving ulixacaltamide maintained response compared with 33% in the placebo group (

 = .0369; Odds Ratio [OR], 2.7; 95% Confidence Interval [CI], 1.06-6.92). The first key secondary endpoint, rate of disease improvement, achieved statistical significance. PGI-C and CGI-S results numerically favored ulixacaltamide but did not reach statistical significance.

“This is incredibly exciting news. For the first time, we have a medication designed specifically for our ET patients,” said Salima Brillman, MD, founder of the Parkinson’s Disease and Movement Disorders Center of Silicon Valley and co-lead investigator of the Essential3 program. “As a clinical researcher and movement disorder specialist, it is very rewarding to see such positive results with the potential to truly change lives. Ulixacaltamide represents more than data on a chart; it is a real opportunity to help people regain independence and improve daily functioning in meaningful ways.”

Praxis Precision Medicines, Inc. Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor. GlobeNewswire News Room. Published December 29, 2025. Accessed December 29, 2025. 

https://www.globenewswire.com/news-release/2025/12/29/3210888/0/en/Praxis-Precision-Medicines-Announces-the-FDA-Has-Granted-Breakthrough-Therapy-Designation-for-Ulixacaltamide-HCl-in-Essential-Tremor.html

‌Praxis Precision Medicines Announces Positive Topline Results from Two Pivotal Phase 3 Studies of Ulixacaltamide HCl in the Essential3 Program for Essential Tremor - Praxis Precision Medicines, Inc. Praxis Precision Medicines, Inc. Published 2025. Accessed December 29, 2025. 

https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-positive-topline-results-1

Ulixacaltamide has received Breakthrough Therapy Designation from the FDA for treating essential tremor, a prevalent movement disorder affecting millions in the US. This designation, based on the Essential3 program, highlights ulixacaltamide's potential to address unmet needs in essential tremor treatment. The drug, a selective T-type calcium channel inhibitor, showed promising results in two phase 3 studies. Study 1 demonstrated significant improvement in daily living activities, while Study 2 confirmed sustained response in patients. These findings suggest ulixacaltamide could significantly enhance treatment options for essential tremor.

The FDA grants breakthrough therapy designation for ulizacaltamine for the treatment of essential tremor. 


Parkinson Disease

The HCPLive Parkinson's disease page is a comprehensive resource for clinical news and insights on PD. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for movement disorders, and more.

FDA Grants Breakthrough Therapy Designation for Ulizacaltamine in Essential Tremor 

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.

 approvals of esketamine for treatment-resistant depression, expanded-use buprenorphine and risperidone injectables, and BrainsWay’s Deep TMS for adolescents with major depressive disorder (MDD), offering clinicians new tools for personalized, effective care.

Clinical trials highlighted promising therapies: TEV-‘749 for schizophrenia, centanafadine and solriamfetol for ADHD, and MM120 (LSD) for generalized anxiety disorder, alongside expert insights on dermatologic comorbidities, psychiatry research updates, and ethical considerations in psychedelic treatments, shaping the evolving psychiatric landscape.

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

The FDA has cleared BrainsWay Ltd’s Deep TMS system for adolescents aged 15–21 years with MDD, announced on November 13, 2025. Supported by extensive real-world data, the noninvasive device delivers daily 20-minute sessions over 4–6 weeks, demonstrating significant reductions in depressive symptoms and comorbid anxiety.

FDA Approves Risperidone Extended-Release Injectable for Bipolar I Disorder

Announced on October 10, 2205, the FDA has approved Teva Pharmaceuticals’ UZEDY, a once-monthly, subcutaneous extended-release risperidone, for adults with bipolar I disorder. Using SteadyTeq™ technology, UZEDY provides controlled drug release, supporting maintenance therapy and addressing treatment gaps previously managed with oral or other long-acting formulations.

FDA Initiates Acetaminophen Label Change, Leucovorin Approval for Cerebral Folate Deficiency

The FDA has initiated a label change for acetaminophen, citing evidence linking prenatal use to increased autism and ADHD risk, while collaborating with GSK to approve leucovorin (Wellcovorin) for cerebral folate deficiency. Both actions aim to enhance awareness, improve safety, and expand treatment options for neurological conditions.

APhA, Coalition of Autism Scientists Cite Insufficient Data to Support Acetaminophen, Autism Link

FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment

Announced on February 24, 2025, the FDA has approved expanded use of Indivior’s SUBLOCADE, a buprenorphine extended-release injection for opioid use disorder, adding thigh, buttock, and upper arm injection sites. Label updates reduce induction to a single dose with one-hour observation, improving adherence and supporting flexible, patient-centered treatment.

FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression

The FDA has approved Johnson & Johnson’s esketamine (SPRAVATO®) nasal spray as the first monotherapy for adults with treatment-resistant depression, which was announced on January 21, 2025. Phase 4 trials demonstrated rapid, superior improvement in MADRS scores within 4 weeks, providing a standalone option for patients unresponsive to oral antidepressants.

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for TEV-‘749, a once-monthly subcutaneous olanzapine extended-release injection for adult schizophrenia. Phase 3 SOLARIS trial data demonstrated efficacy, safety, and high patient, nurse, and physician satisfaction, offering a controlled-release alternative to oral olanzapine.

Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children

Otsuka Pharmaceuticals submitted an NDA to the FDA for centanafadine, a novel NDSRI, for ADHD in patients aged 4–55 years. Four phase 3 trials showed significant, clinically meaningful improvements in ADHD symptoms with once-daily extended-release centanafadine, demonstrating a first-in-class mechanism and favorable tolerability.

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

Johnson & Johnson submitted a supplemental NDA (sNDA) to the FDA for lumateperone (CAPLYTA) to prevent schizophrenia relapse. Phase 3 data showed a 63% reduction in relapse risk, characterized by high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy, supporting its safety and long-term efficacy.

Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial

Axsome Therapeutics’ FOCUS Phase 3 trial showed solriamfetol significantly reduced ADHD symptoms in adults, achieving a 45% mean reduction in AISRS scores versus placebo. Symptom improvement was observed as early as week 1, with a favorable safety and tolerability profile.

Single Dose of MM120 (LSD) Shows Lasting Anxiety Reduction in GAD: Phase 2b Results

A phase 2b trial by MindMed showed a single 100 μg dose of MM120 (LSD) significantly reduced anxiety in adults with GAD, with effects sustained through 12 weeks. Rapid improvements were seen by day 2, demonstrating dose-dependent efficacy and a favorable safety profile.

Single Dose of MM120 Shows Rapid Anxiety Reduction in GAD, With Maurizio Fava, MD

Silent Weight of Psoriasis: Addressing Depression, Anxiety, Stigma in Care

Patients with psoriasis are 1.5 times likely to develop depression, highlighting the importance of routine mental health screening. Experts like Eva Parker, MD, of Vanderbilt Health, emphasize addressing both visible skin symptoms and the emotional impact to improve overall patient well-being.

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

, hosts Steve Levine, MD, and Dominic Sisti, PhD, with guest Amy McGuire, JD, PhD, explore ethical challenges in psychedelic therapies, including consent, cultural integration, dosing, and clinical trial considerations.

Introducing The Gus Alva Perspective, with Gus Alva, MD

The Gus Alva Perspective, hosted by psychiatrist Gus Alva, MD, delivered biweekly expert insights on psychiatry, covering new treatments, research updates, and Southern California Psychiatry Meeting highlights to support clinicians in practice.

In 2025, significant advancements in psychiatry included FDA approvals for esketamine as a monotherapy for treatment-resistant depression, expanded-use buprenorphine, and risperidone injectables. BrainsWay's Deep TMS was cleared for adolescents with MDD. Promising clinical trials featured TEV-‘749 for schizophrenia, centanafadine and solriamfetol for ADHD, and MM120 (LSD) for generalized anxiety disorder. The FDA initiated acetaminophen label changes and approved leucovorin for cerebral folate deficiency. Ethical considerations in psychedelic treatments and the impact of dermatologic comorbidities on mental health were also highlighted.

In 2025, psychiatry saw major FDA approvals, novel treatments, and pivotal clinical updates that are transforming care for depression, ADHD, schizophrenia, and anxiety.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

ADHD

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

Schizophrenia

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

​​Psychiatry in 2025: Year in Review

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.

, driven by rapid therapeutic innovation, evolving clinical guidelines, and a growing emphasis on long-term disease control and patient-centered care. Across inflammatory bowel disease, functional GI disorders, and colorectal cancer prevention, the field saw both an expansion of treatment options and greater clarity around how best to deploy them in clinical practice.

 dominated the year’s headlines, particularly with multiple US Food and Drug Administration (FDA) approvals that reshaped the Crohn’s disease (CD) and ulcerative colitis (UC) landscapes. New and expanded indications for IL-23 inhibitors reflected a shift toward high-efficacy, durable therapies, supported by increasingly robust long-term data and more flexible dosing strategies. At the same time, late-stage trial results for agents such as obefazimod and icotrokinra reinforced the depth of the IBD pipeline, while updated American Gastroenterological Association (AGA) guidelines emphasized earlier use of advanced therapies to improve outcomes.

Beyond IBD, 2025 delivered meaningful progress in broader gastroenterology care. The FDA approval of linaclotide for pediatric 

irritable bowel syndrome with constipation (IBS-C)

 addressed a long-standing unmet need, while new AGA guidance on gastroparesis and US Multi-Society Task Force on Colorectal Cancer (USMSTF) recommendations on bowel preparation highlighted continued efforts to standardize and optimize care. Together, these developments define 2025 as a year of consolidation and forward momentum that strengthened evidence-based practice while setting the stage for the next generation of GI innovation.

FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

On January 15, 2025, the FDA approved Lilly’s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active CD, the therapy’s second approval in IBD since 2023 when it was approved as a first-in-class treatment for moderately to severely active UC. The approval made mirikizumab the first biologic treatment in more than 15 years to have disclosed 2-year phase 3 efficacy data in CD at the time of approval.

FDA Approves Guselkumab (Tremfya) For Crohn Disease

On March 20, 2025, the FDA approved guselkumab (Tremfya) for the treatment of adults with moderately to severely active CD based on data from multiple phase 3 trials, including the GALAXI trials, which found guselkumab outperformed ustekinumab (Stelara) for multiple endoscopic endpoints. With the approval, the agent boasts indications for both moderately to severely active CD and moderately to severely active UC.

FDA Approves Guselkumab (Tremfya) Subcutaneous Induction Regimen for Ulcerative Colitis

On September 19, 2025, the FDA approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya) for the treatment of adults with moderately to severely active UC, making guselkumab the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and CD. The UC SC induction approval was based on results from the phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of guselkumab SC induction therapy in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy and advanced therapies.

FDA Approves Single-Dose Formulation of Mirikizumab-mrkz for Ulcerative Colitis

On October 27, 2025, the FDA approved mirikizumab-mrkz (Omvoh) as a single-injection once-monthly maintenance regimen for adult patients with UC based on results from a phase 1 study comparing a single 200 mg/2 mL subcutaneous injection to a pair of 100 mg/1 mL injections and confirming the bioequivalence of the new 1-dose treatment to the previously approved 2-dose regimen.

FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C

On November 5, 2025, the FDA approved linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population. The approval was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C.

ANTHEM-UC: Icotrokinra (JNJ-2113) Shows Promise for Ulcerative Colitis

On March 10, 2025, Johnson & Johnson announced positive topline results from the phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113) in adults with moderately to severely active UC showing the study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at week 12.

Obefazimod Meets Primary Endpoint in Phase 3 ABTECT Program for Ulcerative Colitis

On July 23, 2025, Abivax SA announced positive topline results from its phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials evaluating obefazimod (ABX464) in adult patients with moderately to severely active UC. Results from both trials showed obefazimod met its FDA primary endpoint of clinical remission at week 8 in the 50 mg once-daily dose regimens.

LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit in Ulcerative Colitis Through 4 Years

On October 7, 2025, Eli Lilly and Company announced data from the phase 3 LUCENT-3 open-label extension study establishing mirikizumab-mrkz (Omvoh) as the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active UC achieve sustained, long-term outcomes through 4 years. Results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%).

AGA Releases Gastroparesis Clinical Practice Guideline, Highlights Unmet Needs

On September 19, 2025, the AGA released its clinical practice guideline on the management of gastroparesis, offering 12 conditional recommendations for the diagnosis and management of the complex gastric motility disorder. The document provides recommendations for ensuring an accurate diagnosis and identifying evidence-based, effective treatments among the available pharmacologic and procedural interventions for patients with idiopathic gastroparesis or gastroparesis related to diabetes.

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active CD, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

USMSTF Guidance on Optimizing Bowel Preparation for Colonoscopy

The USMSTF, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy, released new guidance providing clinical recommendations to address challenges related to bowel preparation for colonoscopy, focusing specifically on outpatients at low risk for inadequate bowel preparation.

In a 6-part HCPLive RX Review, Brian Jacobson, MD, MPH, and Joseph Anderson, MD, discuss their work as co-authors on the recent USMSTF consensus statements and explain why adequate bowel preparation is so important in the context of colonoscopy.

Colonoscopy’s Role in CRC Screening, The Importance of Adequate Bowel Preparation

Bridging Gut and Skin Care: A Call for Collaboration in Inflammatory Disease Management

In this 3-part HCPLive Special Report, advisory board members Adelina Hung, MD, and Raj Chovatiya, MD, PhD, discuss the connection between immune-mediated inflammatory diseases in GI and dermatology, unmet needs in management, and what the future may hold for patient care and drug development.

The year 2025 marked significant advancements in gastroenterology, characterized by therapeutic innovations, updated clinical guidelines, and a focus on long-term disease management. Inflammatory bowel disease (IBD) saw notable FDA approvals, including new treatments for Crohn's disease and ulcerative colitis, emphasizing high-efficacy therapies. Progress extended to broader gastroenterology care with approvals for pediatric IBS-C and new guidelines for gastroparesis and colorectal cancer prevention. These developments underscore a year of consolidation and forward momentum, enhancing evidence-based practice and setting the stage for future innovations in gastrointestinal care.

The gastroenterology year in review covers FDA approvals, IBD breakthroughs, IL-23 therapies, new guidelines, and advances in GI care.

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.

Irritable Bowel Syndrome

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

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Gastroenterology in 2025: Year in Review

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.

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

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.

Heart Failure in 2025: Year in Review

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

The asthma year in review highlights FDA approvals, data, and advances in 2025.

Psoriatic Arthritis

On the HCPLive psoriatic arthritis page, resources on the topics of medical news and expert insight into PsA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on arthritis, 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.

Psoriatic Arthritis in 2025: Year in Review

IgA nephropathy advanced in 2025 with FDA approvals, positive phase 3 trials, and growing disease-modifying therapies


IgA Nephropathy

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

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.

IgA Nephropathy in 2025: Year in Review

Catch up on news headlines highlighted in the dermatology space by HCPLive in 2025 with this Year in Review.

Plaque Psoriasis

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

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 in 2025: Year in Review

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

Seasonal Allergy

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

​​Allergy in 2025: Year in Review

The hepatology year in review highlights FDA approvals, MASH therapies, viral hepatitis advances, cholestatic disease shifts, and evolving clinical guidance.

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.

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

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!

Hepatology in 2025: Year in Review

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

Cardiology in 2025: Year in Review

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Explore five pivotal FDA decisions set for early 2026 that could transform specialty medicine and enhance treatment options across various conditions.

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