New Insight with Dr. Veeral Sheth

Don’t Miss a Beat

Crisis Point

Treatment Strategies for CSU

Among urticaria experts, a central goal in managing CSU is achieving complete disease control. Although this is a widely shared aspiration, clinicians also emphasize the importance of incorporating patient preferences into treatment plans. Some individuals may prioritize avoiding adverse effects or polypharmacy, even if it means tolerating occasional symptoms, whereas others are willing to pursue aggressive treatment for full symptom relief. The ability to control CSU is generally attainable, especially with potent therapies like cyclosporine, though higher doses may introduce unwanted adverse effects.

Currently, most available therapies for CSU focus on symptom suppression rather than altering the underlying disease course. A major unmet need in the field is true disease modification—treatments that could shorten disease duration or even induce remission. This shift from long-term control to potential cure is an exciting possibility for future therapies in the development pipeline, offering patients hope for not only managing symptoms but also achieving lasting relief.

In terms of long-term strategy, the current clinical approach emphasizes safe and sustained suppression while waiting for natural remission, which studies suggest eventually occurs in many patients—but sometimes only after years or even decades. If a therapy were developed that could actively modify disease progression and accelerate remission, it would significantly change both treatment decisions and patient outcomes, offering shorter treatment durations and possibly permanent resolution of symptoms.

Videos

A panelist discusses how the current goal in managing chronic spontaneous urticaria (CSU) is complete symptom control, balanced with patient preferences, while highlighting the future promise of disease-modifying therapies that could shorten disease duration and shift care from long-term suppression to potential remission.

Video Series

Insights

 Insights page is a resource for professional video interviews with leading clinical experts and investigators across all specialties of medicine.

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.

The first half of 2025 has brought several important US Food and Drug Administration (FDA) updates in psychiatry, ranging from new drug approvals and label expansions to promising trial data. These developments offer fresh treatment options and improved care strategies for conditions such as depression, schizophrenia, bipolar disorder, ADHD, and opioid use disorder (OUD).

FDA Approvals: SUBLOCADE for OUD, Esketamine for TRD

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

The FDA approved expanded use of the buprenorphine extended-release injection (SUBLOCADE) for OUD, allowing administration in the thigh, buttock, and upper arm in addition to the abdomen. The updated label also shortens induction from a 7-day lead-in to a single transmucosal dose with a 1-hour observation. These changes aim to improve flexibility, adherence, and outcomes for patients.

FDA Approves Label Update for Viloxazine Capsules to Include New Lactation Data

The FDA approved a label update for viloxazine extended-release capsules (Quelbree) to include new lactation data, showing low transfer into breastmilk. The update also details viloxazine’s serotonin 5-HT2C receptor activity and norepinephrine transporter inhibition, expanding understanding of its pharmacodynamics.

Approved for ADHD in children and adults, viloxazine may increase blood pressure, heart rate, or cause manic episodes. The label update follows a study of 15 lactating women and supports more informed treatment decisions for breastfeeding patients managing ADHD with viloxazine.

FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression

The FDA approved esketamine (SPRAVATO) nasal spray as the first monotherapy for treatment-resistant depression (TRD) in adults. This approval follows a phase 4 trial showing rapid symptom improvement and superior MADRS score reductions at 4 weeks versus placebo. Esketamine previously required use alongside oral antidepressants, but can now be used alone, offering flexibility for patients who don’t respond to or tolerate oral treatments.

PharmaTher Receives New Early June FDA Goal Date for Ketamine

PharmaTher received a new FDA goal date of June 4, 2025, for ketamine’s potential approval, covering anesthesia, pain, mental health, and neurological indications. The update followed an Amendment Acknowledgment Letter addressing minor manufacturing and microbiology issues from a prior complete response letter. No new clinical trials were requested.

PharmaTher aims to ease the longstanding ketamine shortage—on the FDA’s drug shortage list since 2018—that has contributed to the rise in unregulated compounded ketamine. If approved, PharmaTher could become a key supplier and help curb safety concerns tied to compounded use.

FDA Accepts sNDA for Risperidone Extended-Release Injectable Suspension for Bipolar I Disorder

The FDA has accepted the supplemental new drug application (sNDA) for UZEDY, a risperidone extended-release injectable, to treat adults with bipolar I disorder. Already approved for schizophrenia in 2023, UZEDY uses copolymer technology for sustained release. Teva and Medincell emphasized UZEDY’s potential to address nonadherence in bipolar care, though safety and efficacy for this new indication still need to be evaluated in clinical trials.

What’s Moving in the Psychiatry Pipeline

Compass Pathways’ COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial

Compass Pathways’ COMP360 psilocybin significantly reduced depression severity at 6 weeks in TRD patients during the phase 3 trial, with no new safety concerns.

Cobenfy Falls Short in Phase 3 ARISE Trial as Adjunctive Schizophrenia Therapy

Cobenfy (xanomeline-trospium) failed to show significant benefit over placebo as adjunctive schizophrenia therapy, though some subgroups showed promise.

Expert Insights: LB-102, Podcast Episodes on Ethics and SoCal Psych Previews

LB-102 Significantly Improves Disease Severity in Acute Schizophrenia, with John Kane, MD

LB-102 showed significant improvement in acute schizophrenia severity, reducing CGI-S and PANSS scores with good tolerability in a phase 2 trial.

The Gus Alva Perspective: SoCal Psych Preview—Schizophrenia Updates, with Jonathan Meyer, MD

At the SoCal Psychiatry Conference, Jonathan Meyer, MD, previewed xanomeline-trospium, a novel schizophrenia treatment improving symptoms with fewer adverse events.

Gus Alva Perspective

The Gus Alva Perspective: SoCal Psych Preview—Tardive Dyskinesia, with Jonathan Meyer, MD

Jonathan Meyer previewed his SoCal Psychiatry session on tardive dyskinesia, emphasizing proactive management and its psychosocial impact.

The Gus Alva Perspective: SoCal Psych Preview—Metabolic Revolution in Mood Disorders, with Roger McIntyre, MD

Roger McIntyre previewed his keynote on targeting metabolic systems to treat and prevent mood disorders at the 2025 SoCal Psychiatry Conference.

Medical Ethics Unpacked: Shifting Vaccine Regulation and Policy, with Jason Schwartz, PhD

Jason Schwartz, PhD, discusses vaccine ethics, public trust, and COVID-19’s impact on immunization attitudes and policy challenges.

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

This episode explores ethical challenges of psychedelic therapies, including consent, access, cultural integration, dosing, and regulatory complexities.

Medical Ethics Unpacked: GLP-1 Allocation and Challenges of Equitable Access

This episode addresses GLP-1 drug allocation, which poses ethical challenges balancing fairness, access disparities, prioritization, adherence, and policies for obesity and diabetes treatment equity.

Articles

The first half of 2025 has seen significant FDA updates in psychiatry, including new drug approvals and label expansions. Notable developments include the approval of SUBLOCADE for opioid use disorder (OUD) with expanded administration sites and a streamlined induction process, and esketamine as the first monotherapy for treatment-resistant depression (TRD). Additionally, viloxazine capsules received a label update with new lactation data. The FDA also accepted a supplemental application for risperidone for bipolar I disorder. Promising trial data for psilocybin and LB-102 highlight ongoing advancements in psychiatric treatment options.

5 FDA updates in psychiatry from the first half of 2025, plus other pipeline developments in psychiatry for depression, schizophrenia, and OUD.

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.

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.

5 FDA Updates in Psychiatry from the First Half of 2025

Evan Dellon, MD, MPH, is a professor in the division of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at UNC School of Medicine.

Joy Chang, MD, MS, is an assistant professor of medicine in the division of gastroenterology at the University of Michigan in Ann Arbor.

Role of Inflammation and Atopic Presentations in EoE

EoE is diagnosed as a clinicopathological disorder requiring both clinical symptoms and histological confirmation. The diagnosis necessitates characteristic esophageal dysfunction symptoms combined with pathological evidence of 15 or more eosinophils per high-power field on esophageal biopsy. Upper endoscopy with biopsy remains the gold standard diagnostic procedure, as it provides essential histological evidence while also revealing characteristic endoscopic findings that support the diagnosis.

During endoscopy, clinicians should conduct a detailed examination of the esophageal mucosa rather than quickly passing through to the stomach. Key endoscopic features include edema with loss of normal vascular patterns, concentric rings extending down the esophageal length, white exudates appearing as small specks, longitudinal furrows resembling spokes when viewed down the esophageal barrel, and strictures or narrowing from fibrotic scarring. These strictures can be subtle, requiring careful observation rather than simply noting when the endoscope encounters resistance. However, patients can have EoE with completely normal-appearing esophageal mucosa, emphasizing the importance of histological confirmation.

Pediatric presentations typically show more acute exudative patterns with white exudates, vascular pattern loss, and edema compared to the strictures and rings more commonly seen in adults. Diagnostic challenges include biopsy variability because EoE presents as a patchy disease, potentially leading to sampling errors. The 2011 diagnostic guidelines acknowledge that patients may have fewer than 15 eosinophils if they are receiving concurrent treatment for other atopic conditions, as inhaled or intranasal steroids can partially treat esophageal inflammation. Additional challenges include parental skepticism when symptoms are intermittent, such as infrequent food impactions, and determining appropriate age thresholds for performing endoscopy in young children to balance diagnostic necessity against procedural risks and anesthesia exposure.

Panelists discuss how eosinophilic esophagitis (EoE) diagnosis requires both clinical symptoms and histologic confirmation through upper endoscopy with biopsies showing 15 or more eosinophils per high-power field, while identifying key endoscopic features such as edema, rings, exudates, furrows, and strictures, though diagnostic challenges include biopsy variability and parental recognition of symptoms in pediatric cases.

Recommended Diagnostic Procedures for EoE

Panelists discuss how emerging treatment modalities including digital therapeutics and novel pharmaceutical agents represent an exciting new frontier that could elevate the standard of care for schizophrenia patients when combined with traditional approaches.

Emerging Treatment Modalities and Elevating Standard of Care in Schizophrenia

Video content above is prompted by the following: 

The current landscape of schizophrenia treatment represents an exciting frontier with multiple emerging therapeutic modalities under investigation. Beyond xanomeline trospium chloride, researchers are exploring various novel compounds including eloterant, SEP-363856, ulotaront, and ACP-204, each targeting different neurobiological pathways. Digital therapeutics represent another promising avenue, particularly for addressing cognitive and negative symptoms that have been challenging to treat with traditional pharmacological approaches. This convergence of pharmaceutical innovation and digital health technologies offers unprecedented opportunities for comprehensive treatment strategies.

The paradigm shift in schizophrenia treatment extends beyond individual medications to encompass a broader toolkit approach for healthcare providers. Like contractors who utilize both traditional tools and modern equipment, clinicians must embrace both established therapies and emerging interventions to provide optimal patient care. The integration of novel pharmacological agents with digital therapeutics, cognitive behavioral therapy, and other evidence-based interventions creates possibilities for personalized treatment approaches that address the complex, multifaceted nature of schizophrenia.

Elevating the standard of care requires ongoing education, advocacy, and early adoption of proven therapeutic innovations. Healthcare providers have a responsibility to educate patients, families, and caregivers about all available treatment options, ensuring informed decision-making and optimal outcomes. The combination of new mechanisms of action, improved safety profiles, and complementary therapeutic modalities positions the field to address previously unmet needs in schizophrenia treatment. This evolution toward earlier intervention with more effective, tolerable treatments offers hope for significantly improving long-term outcomes and quality of life for individuals living with schizophrenia.

Peers Perspectives

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.

Here is a 300-word summary on distinguishing EoE from other gastrointestinal disorders:

Differentiating EoE from other gastrointestinal conditions presents significant diagnostic challenges, particularly because EoE remains relatively uncommon compared with more prevalent conditions such as gastroesophageal reflux disease (GERD), which can also cause esophageal eosinophilia and overlapping symptoms. The differential diagnosis requires careful consideration of multiple conditions that can present with similar clinical and histological features.

Key conditions in the differential diagnosis include GERD, which represents the most common alternative diagnosis; hypereosinophilic syndrome, where peripheral eosinophilia targets the gastrointestinal tract; celiac disease; Crohn disease, with potential comorbid esophageal inflammation; and achalasia in adult populations. The diagnostic approach emphasizes comprehensive clinical assessment rather than relying solely on histological criteria. Although eosinophil counts of 15 or more per high-power field suggest EoE, this finding alone is insufficient for diagnosis and must be interpreted within the appropriate clinical context to avoid misdiagnosis.

Clinical differentiation focuses on taking a detailed history and endoscopic findings. GERD typically presents with heartburn, regurgitation, family history of reflux, and endoscopic evidence of ulceration or friable esophageal mucosa. In contrast, EoE often presents with dysphagia in younger patients, accompanied by bland-appearing mucosa with characteristic thickening and fibrotic changes. Age of presentation provides additional diagnostic clues, as EoE typically manifests earlier in life than other esophageal disorders. The diagnostic process acknowledges that patients may have concurrent conditions or that symptoms can be highly variable, ranging from intermittent episodes to daily occurrences. Understanding the depth of tissue involvement remains an ongoing challenge, as it is unclear whether EoE affects only the epithelium or extends deeper into tissue spaces, potentially influencing treatment approaches and explaining the dysfunction observed in patients with this complex inflammatory condition.

Panelists discuss how distinguishing eosinophilic esophagitis (EoE) from other conditions such as gastroesophageal reflux disease requires careful clinical context evaluation. They note that not all esophageal eosinophilia above 15 per high-power field indicates EoE and emphasize the importance of considering patient history, endoscopic findings, symptom patterns, and potential comorbid conditions such as hypereosinophilic syndrome, celiac disease, or achalasia.

Distinguishing EoE From Other GI Disorders

Abigail Brooks is an assistant 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 Q2 recap for gastroenterology spotlights top coverage from DDW, expert perspective on the importance of multidisciplinary care, and other new research.

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.

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.

C Difficile Infection

C. difficile condition center page, resources on the topics of medical news and expert insight into Clostridium difficile can be found. Content includes articles, interviews, videos, podcasts, and breaking news on C. diff research, treatment, and drug development.

Q2 2025 Recap: Gastroenterology News and Updates

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.

Based on 8 major questions and consisting of 9 formal recommendations, the SCAI’s guidelines aim to advise clinicians on what treatments to use when.

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...

SCAI Releases First Ever Guidelines for Managing Chronic Venous Disease

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

Q2 2025 saw new therapies approved for a number of rare disease indications, multiple of which serve as the first disease-modifying therapies in the landscape.

Pulmonology

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

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Q2 2025 Recap: 7 Top FDA Approvals

Robert Sidbury, MD, MPH, is the division head of dermatology at Seattle Children's Hospital and a professor of pediatrics at the University of Washington School of Medicine.

Following the AAD guideline update on atopic dermatitis treatments, Sidbury speaks to the significance of the guideline recommendations for patients and clinicians.

Atopic Dermatitis

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

Dermatology

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

Significance of AAD Guideline Updates for Atopic Dermatitis, with Robert Sidbury, MD, MPH

Key FDA approvals, clinical trial insights, and expert commentary in allergy care from the first half of 2025.

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.

7 Allergy FDA News and 2 Interview Spotlights from First Half of 2025

The Q2 recap for nephrology spotlights key FDA decisions and top coverage from the 62nd European Renal Association Congress.

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

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.

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.

Focal Segmental Glomerulosclerosis

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

Chronic Kidney Disease

Q2 2025 Recap: Nephrology News and Updates

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.

Our recap of Q2 2025 in cardiology spotlights 3 FDA headlines, trial news, and new episodes of Don't Miss a Beat.

Dyslipidemia

Q2 2025 Recap: Cardiology News and Updates

Q2 2025 saw new therapies approved for rare rheumatological conditions and exciting research out of EULAR.

Q2 2025 Recap: 7 Rheumatology Updates to Know

According to recent research, more patients surviving heart diseases correlates directly to higher mortality rates for ischemic and chronic heart conditions.

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.

Mortality from Chronic Heart Disease Increases as Heart Attack Mortality Falls

Explore key advancements in endocrinology from Q2 2025, including FDA approvals and groundbreaking diabetes research shaping future treatments.

Type 2 Diabetes

Hormonal Disorders

Obesity Management

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

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.

Latest News

Treatment Strategies for CSU

5 FDA Updates in Psychiatry from the First Half of 2025

Recommended Diagnostic Procedures for EoE

Emerging Treatment Modalities and Elevating Standard of Care in Schizophrenia

Distinguishing EoE From Other GI Disorders