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.

 landscape was limited to immunosuppressive strategies and supportive care, such as blood pressure management and RAAS inhibition, leaving many patients to experience ongoing disease progression or recurrence after kidney transplantation. The scarcity of targeted therapies makes 2025 a landmark year for this rare kidney disease.

In March 2025, the US Food and Drug Administration (FDA) approved oral iptacopan (Fabhalta) for adults with C3G, demonstrating significant proteinuria reduction and kidney function stabilization in the phase 3 APPEAR-C3G trial. Later in July, the FDA approved pegcetacoplan (Empaveli) for adolescents and adults with C3G, including those with post-transplant recurrence. Phase 3 VALIANT trial data showed durable complement inhibition, proteinuria reduction, stabilization of estimated glomerular filtration rate (eGFR), and evidence of C3 deposit clearance.

These approvals signal the first disease-modifying therapies for C3G, moving management beyond nonspecific immunosuppression and supportive care and offering the potential to meaningfully alter disease trajectory in both native and post-transplant kidneys.

’s 2025 editorial coverage of the emerging treatment landscape for C3G and understand its implications for kidney care.

FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy

Novartis announced FDA approval of oral iptacopan (Fabhalta) on March 20, 2025, for adults with C3G to reduce proteinuria. This first-ever approval for the ultra-rare disease was based on phase 3 APPEAR-C3G trial data, representing a milestone in targeted complement therapy and offering a new oral alternative for disease management.

FDA Approves Pegcetacoplan (Empaveli) for C3 Glomerulopathy, IC-MPGN

Apellis Pharmaceuticals’ pegcetacoplan (Empaveli) was approved for patients ≥12 years of age with C3G or primary immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), including post-transplant disease recurrence. 

Announced on July 28, 2025, the approval was supported by positive 26-week results from the phase 3 VALIANT trial, the largest single study in these rare diseases. The FDA clearance provides clinicians with a targeted therapy stabilizing kidney function while addressing complement-mediated pathology across age groups and transplant settings.

Phase 3 VALIANT Results for Pegcetacoplan In C3G, IC-MPGN, With Andrew Bomback, MD

VALIANT demonstrated a 68% reduction in proteinuria and stabilization of kidney function in adult and adolescent patients with C3G and IC-MPGN. Evidence of C3 deposit clearance, including in post-transplant recurrence, highlights pegcetacoplan’s ability to directly target pathogenic complement activity. These results signal a meaningful shift toward precision, mechanism-based therapy in a condition that previously relied on nonspecific immunosuppression.

APPEAR-C3G: Iptacopan Shows Proteinuria Reduction, eGFR Benefits in C3G

Phase 3 APPEAR-C3G data showed iptacopan produced rapid and sustained proteinuria reduction, stabilized eGFR, and decreased C3 deposits over 12 months in patients with biopsy-confirmed C3G.

 Iptacopan met the primary endpoint of reducing 24-hour urine protein-to-creatinine ratio (UPCR) by 35.1% (95% Confidence Interval [CI], 13.80 to 51.10; 

 = .0014), with sustained reductions at 12 months. The oral alternative complement pathway inhibitor’s efficacy reinforces the emergence of complement-targeted therapies as a new standard for ultra-rare glomerular diseases, potentially improving long-term renal outcomes.

C3G During Pregnancy Linked to Adverse Renal, Obstetric Outcomes

A retrospective analysis from the University of Iowa’s C3G Natural History Study found higher risks of preeclampsia, prematurity, and renal decline in pregnant patients with C3G compared with healthy controls.

“These data provide a preliminary maternal-risk profile for C3G patients who are considering pregnancy and allow for certain risk scenarios to be considered and managed prospectively,” Lauren Fergus, of the Molecular Otolaryngology and Renal Research Laboratories at the University of Iowa, wrote. “Ultimately, the elevated chances of adverse events support the need for multidisciplinary pre- and peri-pregnancy care involving obstetrics, nephrology, and pediatrics as a mechanism for improving outcomes of both mother and baby.”

The findings underscore the importance of coordinated, personalized care in C3G to mitigate both maternal and fetal risks.

C3G, IC-MPGN Report A Disruptive Burden Regardless of Slowed Disease Progression

A multinational, cross-sectional survey found patients and caregivers experience substantial clinical, economic, and quality-of-life impacts, even when disease progression is slow or stable. These results emphasize that, despite emerging therapies, ongoing support and management strategies remain critical to address the broader burden of ultra-rare glomerular diseases.

Pegcetacoplan's Approval & Shifting C3G Landscape, with Sayna Norouzi, MD

For a condition previously lacking approved therapies and relying on nonspecific immunosuppressants, the arrival of two targeted options in under a year marks a dramatic shift for patients and clinicians.

“This is really, really groundbreaking news for our patients and for us as nephrologists because for years and years, patients with C3G came to our clinics and we didn't have any specific FDA-approved medications for them,” said Sayna Norouzi, MD, assistant professor of medicine, clinical nephrologist, and founder and director of the Glomerular Disease and Polycystic Kidney Disease Clinics at Loma Linda University Medical Center.

The new approvals signal a turning point in C3G care, moving toward mechanism-based interventions with potential to improve long-term kidney outcomes and patient quality of life.

VALIANT: Pegcetacoplan Shows Sustained Efficacy in C3G and IC-MPGN, With Carla Nester, MD

Expert Perspectives: Iptacopan FDA Approval for C3 Glomerulopathy

For additional insight into the significance of the approval of iptacopan and its impact on C3G care, the editorial team of 

 spoke with Gerald Appel, MD, a professor of clinical medicine, director of clinical nephrology, and director of the Glomerular Disease Center at Columbia University; Andrew Bomback, MD, an assistant professor of medicine at Columbia University Medical Center; and Jared Hassler, MD, a pathologist at the Temple University Hospital.

Articles

The landscape of C3 glomerulopathy (C3G) treatment has evolved significantly with the FDA's approval of two targeted therapies in 2025. Oral iptacopan (Fabhalta) and pegcetacoplan (Empaveli) have shown promising results in reducing proteinuria and stabilizing kidney function, marking a shift from traditional immunosuppressive strategies. These approvals represent the first disease-modifying therapies for C3G, offering new hope for patients, including those with post-transplant recurrence. Despite these advancements, the disease continues to impose a substantial burden on patients' quality of life, necessitating ongoing support and management.

C3G treatment advances in 2025 with FDA approvals of iptacopan and pegcetacoplan, offering disease-modifying options


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.

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.

C3 Glomerulopathy

The HCPLive C3 glomerulopathy page is a resource for medical news and expert insights on C3G. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in C3G, and more.

C3 Glomerulopathy in 2025: Year in Review

 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/

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


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.

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.

IgA Nephropathy in 2025: Year in Review

New CDC recommendations on hepatitis B vaccination raise concerns over increased infections and healthcare costs, complicating public health efforts.

Infectious Disease

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on viruses, infections, and bacteria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for COVID-19, influenza, vaccine-preventable diseases, and more.

This Year In Medicine

New Hepatitis B Vaccine Recommendation Serves as a Blueprint for Federal Vaccine Policy Going Forward 

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.

Latest News

C3 Glomerulopathy in 2025: Year in Review

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

Skin of Color Savvy: Highlights from 2025

FDA Grants Breakthrough Therapy Designation for Ulizacaltamine in Essential Tremor

​​Psychiatry in 2025: Year in Review

Psychiatry in 2025: Year in Review