Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration approvals of omidubicel-onlv (Omisirge) for the treatment of severe aplastic anemia, etuvetidigene autotemcel (Waskyra) for Wiskott-Aldrich syndrome, gepotidacin (Blujepa) for patients with uncomplicated urogenital gonorrhea, trofinetide (Daybue Stix) for oral solution for Rett syndrome, and berotralstat (Orladeyo) oral granules for patients with hereditary angioedema (HAE).

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of December 7, 2025—let’s jump in!

FDA Approves Omidubicel-onlv (Omisirge) As First Cellular Severe Aplastic Anemia Therapy

On December 8, 2025, the FDA approved Ayrmid’s omidubicel-onlv (Omisirge) for the treatment of severe aplastic anemia, making it the first hematopoietic stem cell transplant therapy for this indication. The treatment addresses the limitations of umbilical cord blood as a source including delayed hematopoietic recovery and increased infections and provides additional graft options for patients with severe aplastic anemia who need hematopoietic stem cell transplant.

FDA Approves Etuvetidigene Autotemcel (Waskyra) For Wiskott-Aldrich Syndrome

On December 9, 2025, the FDA approved etuvetidigene autotemcel (Waskyra), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome. It is indicated for pediatric patients ≥ 6 months of age and adults with Wiskott-Aldrich syndrome who have a mutation in the 

 gene and for whom hematopoietic stem cell transplantation is appropriate and no suitable human leukocyte antigen-matched related stem cell donor is available.

FDA Approves Gepotidacin as Oral Treatment of Uncomplicated Urogential Gonorrhea

On December 11, 2025, the FDA approved GSK’s gepotidacin as an oral option for adult and pediatric patients ≥ 12 years of age weighing ≥ 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of 

. The decision follows the FDA approval of gepotidacin earlier this year as an oral treatment for female adult and paediatric patients ≥ 12 years of age weighing ≥40 kg with uncomplicated urinary tract infection.

FDA Approves New Powder Formulation of Trofinetide (Daybue) for Rett Syndrome

On December 12, 2025, the FDA approved Acadia Pharmaceuticals’ trofinetide (Daybue Stix) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients ≥ 2 years of age. The new formulation is expected to deliver the same efficacy and safety profile of trofinetide oral solution, while offering children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their trofinetide treatment.

FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE

On December 12, 2025, the FDA approved BioCryst’s berotralstat (Orladeyo) oral granules for patients with HAE aged 2 – 11 years. The decision expands upon berotralstat’s 2020 FDA approval for the prevention of HAE attacks in adults and children aged ≥ 12 years.

Brooks A. FDA Approves Omidubicel-onlv (Omisirge) As First Cellular Severe Aplastic Anemia Therapy. HCPLive. December 8, 2025. Accessed December 12, 2025. 

https://www.hcplive.com/view/fda-approves-omidubicel-onlv-omisirge-first-cellular-severe-aplastic-anemia-therapy

Brooks A. FDA Approves Etuvetidigene Autotemcel (Waskyra) For Wiskott-Aldrich Syndrome. HCPLive. December 9, 2025. Accessed December 12, 2025. 

https://www.hcplive.com/view/fda-approves-etuvetidigene-autotemcel-waskyra-wiskott-aldrich-syndrome

Smith T. FDA Approves Gepotidacin as Oral Treatment of Uncomplicated Urogential Gonorrhea. HCPLive. December 11, 2025. Accessed December 12, 2025. 

https://www.hcplive.com/view/fda-approves-gepotidacin-oral-treatment-uncomplicated-urogential-gonorrhea

Brooks A. FDA Approves New Powder Formulation of Trofinetide (Daybue) for Rett Syndrome. HCPLive. December 12, 2025. Accessed December 12, 2025. 

https://www.hcplive.com/view/fda-approves-new-powder-formulation-of-trofinetide-daybue-for-rett-syndrome

Derman C. FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE. HCPLive. December 12, 2025. Accessed December 12, 2025. 

https://www.hcplive.com/view/fda-approves-oral-berotralstat-children-aged-2-11-years-hae

Articles

Recent FDA approvals have introduced significant advancements in treatment options for various conditions. Omidubicel-onlv (Omisirge) is now the first cellular therapy for severe aplastic anemia, addressing limitations of umbilical cord blood. Etuvetidigene autotemcel (Waskyra) offers a gene therapy solution for Wiskott-Aldrich syndrome. Gepotidacin provides an oral treatment for uncomplicated urogenital gonorrhea. Trofinetide (Daybue Stix) introduces a new powder formulation for Rett syndrome, enhancing treatment flexibility. Berotralstat (Orladeyo) oral granules expand treatment options for hereditary angioedema in younger children.

Stay updated with the latest healthcare breakthroughs, including several new FDA approvals, in this week's essential news roundup.

News

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Hematology

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The HCPFive: Top News for Healthcare Providers from the Week of 12/07

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.

Image Credit: US Food and Drug Administration

Announced by parent company Milestone Pharmaceuticals on December 12, 2025, the 

 has approved etripamil (Cardamyst) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

The decision marks the first time that more than 2 million people in the US with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. As described in the release from Milestone, etripamil is expected to be available in retail pharmacies in the first quarter of 2026.

“Some people with PSVT have endured years of anxiety, fearing their next episode and the stress and disruption of emergency department visits,” James Ip, MD, an etripamil investigator, said in a statement.

 “CARDAMYST will give many of them the ability to administer a medication themselves that can quickly stop their PSVT episode and potentially avoid a hospital trip or a call to emergency services.”

Etripamil is a novel calcium channel blocker nasal spray developed to treat frequent and highly symptomatic episodes of 

paroxysmal supraventricular tachycardia (PSVT)

. It is designed as a rapid response therapy to be self-administered by patients, bypassing the need for medical oversight. It offers patients more control over their condition via active management.

Etripamil’s efficacy has been proven across various trials in the overarching NODE program, including the NODE-1, NODE-301 parts 1 and 2, NODE-302, and NODE-303 trials. A collective analysis of all of these trials was presented at the American Heart Association’s 2025 Scientific Sessions in November 2025, which highlighted the overall efficacy, safety, and test-dose tolerability of etripamil in patients with PSVT.

During this collective analysis, efficacy measures included the proportion of patients converting from PSVT to normal sinus rhythm (SR) within 30 minutes and the median times to conversion across all the included phase 3 studies. Safety data for treatment-emergent adverse events (TEAEs), serious adverse events, and test dose tolerability from phase 2 and 3 studies were also summarized.

The Kaplan-Meier estimate during this analysis displayed a substantial 59.6% of patients exposed to etripamil converted to normal SR within 30 minutes, with a median time to conversion of 18.5 minutes (95% CI, 15.7-21). The proportions of placebo group patients converting from SVT to SR by 30 minutes ranged from 26.7% to 34.7%, while estimates of conversion with etripamil at 60 minutes for the individual studies ranged from 63.2% to 73.5%.

Additionally, the combined analysis displayed largely mild and transient treatment-emergent adverse events, primarily nasal congestion, nasal discomfort, throat irritation, rhinorrhea, and epistaxis. A total of 1107 patients took ≥1 etripamil test dose while in SR, and no significant change in average baseline heart rate or blood pressure was observed within 45 minutes of administration. Test dose failure occurred in only 1.4% of patients (n = 16). Investigators determined no need for a pretreatment dose, highlighting etripamil’s favorable tolerability.

“CARDAMYST is a novel at-the-ready treatment option that addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.

 “The FDA approval of CARDAMYST is a watershed moment for Milestone and a gratifying event for our team members, patients, clinical investigators, and health care providers who participated in the development program, all of whom I sincerely thank for their dedication, counsel, and collaboration toward this important achievement.”

Milestone Pharmaceuticals. Milestone Receives FDA Approval of CARDAMYST™ (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT). December 12, 2025. Accessed December 12, 2025. https://www.globenewswire.com/news-release/2025/12/13/3204944/0/en/Milestone-Receives-FDA-Approval-of-CARDAMYST-etripamil-as-First-and-Only-Self-Administered-Nasal-Spray-for-Adults-with-Paroxysmal-Supraventricular-Tachycardia-PSVT.html

2. Gardner K. Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST (etripamil) Nasal Spray. Milestone Pharmaceuticals. July 11, 2025. Accessed December 9, 2025. 

https://investors.milestonepharma.com/news-releases/news-release-details/milestone-pharmaceuticals-announces-fda-acceptance-companys

3. Ip J, Noseworthy P, Piccini J, et al. Combined Efficacy, Safety, and Test Dose Tolerability of Etripamil for Acute Paroxysmal Supraventricular Tachycardia (PSVT) Across Multiple Clinical Trials. 

. November 3, 2025. Accessed December 9, 2025. 

https://www.ahajournals.org/doi/10.1161/circ.152.suppl_3.4366812

The FDA has approved etripamil (Cardamyst) nasal spray for self-administration in adults with paroxysmal supraventricular tachycardia (PSVT), offering a rapid-acting treatment outside healthcare settings. This novel calcium channel blocker allows patients to manage episodes independently, reducing emergency visits. Clinical trials demonstrated its efficacy, with 59.6% of patients converting to normal sinus rhythm within 30 minutes. The treatment showed mild, transient adverse events and high tolerability. Etripamil's approval marks a significant advancement in PSVT management, providing patients with greater control over their condition.

The FDA has approved etripamil nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm.

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...

Arrhythmia

FDA News

FDA Approves Etripamil (Cardamyst) Nasal Spray for PSVT

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.

 patients do not understand commonly-used skin-cancer–related terms and phrases, with the youngest age cohort scoring significantly lower than older individuals.

Juna Khang, BA, from the department of dermatology at Beth Israel Deaconess Medical Center, led a team of investigators in authoring this analysis of survey data. Khang et al had sought to explore patient comprehension of cutaneous oncology-related terms, factors impacting understanding, and other related factors.

In this study, the team of investigators highlighted the importance of communicating with patients in dermatology settings with regard to skin cancer-related concerns.

“Effective patient-physician communication is essential to quality health care and impacts health outcomes,” Khang and colleagues wrote.

 “This survey study aimed to assess patient understanding of commonly used cutaneous oncology-related words and phrases and identify factors that influence comprehension.”

The investigators provided an anonymous, voluntary questionnaire to patients at Beth Israel Deaconess Medical Center's general dermatology clinics. This took place during a 2-week timeframe in May 2025. Those who took part in the questionnaire provided demographic information and filled out a series of multiple-choice inquiries designed to assess their awareness of 13 often-used terms related to skin cancer.

In this survey, each question offered only a single correct answer. Those who were visiting for cosmetic concerns, those with cognitive impairment, and those who required interpreter services were not included in Khang et al's analysis. The investigators sought to explore the connection between demographic data and overall comprehension among patients, represented by the mean percentage of correct responses. To do this, they performed multivariable linear regression adjusted for all demographic variables. They defined statistical significance as 

Overall, Khang and coauthors' survey results revealed considerable variation in patients’ familiarity with widely-used terminology used to describe skin cancer and skin cancer management. The questionnaire concentrated primarily on neoplasm-related vocabulary and terms related to diagnostic or therapeutic procedures, so the analysis was unable to capture understanding of language related to inflammatory skin diseases. However, the survey's narrower scope allowed Khang and colleagues to explore specific gaps in skin cancer awareness.

Specifically, among the 182 individuals who met the survey's criteria for eligibility, 166 filled out the full survey. This reflected a 90.4% response rate. Among those who did so, 54.8% were women, 44.6% were men, and 1 subjects identified as nonbinary (0.6%). Scores on patients' comprehension showed significant differences across demographic cohorts. Looking at adults aged 60 years or older, individuals between 18 - 29 years demonstrated significantly poorer performance by comparison, with a β coefficient of –17.88 (95% CI, –28.37 to –7.39; 

Additionally, Khang et al found participants who held graduate-level degrees and those with more than 5 previous dermatology appointments attained the best scores. Specific term awareness was also shown to have varied widely. Nearly all respondent (95.0%) were correctly able to point to the definitions of “skin biopsy” and “topical.” In contrast, however, only 13.6% were aware of the meaning of “actinic."

21.6% were shown to have recognized the definition of “dysplastic nevus.” Roughly 61.1% understood “pathology results,” and 64.2% were able to accurately define “clear margins.” Most of those who responded to the survey successfully recognized basal cell carcinoma (69.9%), melanoma (82.2%), and squamous cell carcinoma (59.4%) as types of skin cancer. However, Khang and colleagues did highlight some of the more notable limitations of their survey and analysis of the results.

Given the number of respondents identifying as Black, Asian, multiracial, or Hispanic/Latino was small, the analysis could not draw reliable conclusions about distinctions specifically across these cohorts of patients. They also highlighted the single-center setting and the general lack of information about factors such as family history or the underlying reason for each dermatology center interaction. The investigative team also highlighted the high level of overall comprehension compared to the general population, pointing to the relatively large proportion of health care workers in the greater Boston region.

“Future research should explore interventions to improve patient education and examine whether tailored language improves understanding and engagement in dermatologic care,” the investigative team concluded.

Khang J, Karatas E, Brag K, et al. Patient Comprehension of Skin Cancer–Related Terminology. JAMA Dermatol. Published online December 10, 2025. 

Street RL Jr, Makoul G, Epstein RM, et al. How does communication heal? Pathways linking clinician-patient communication to health outcomes. Patient Educ Couns. 2009 Mar;74(3):295-301. 

A recent study highlights a significant gap in dermatology patients' understanding of skin cancer-related terminology, with younger patients scoring lower than older ones. Conducted at Beth Israel Deaconess Medical Center, the survey assessed comprehension of 13 common terms, revealing demographic influences on understanding. Higher education and frequent dermatology visits correlated with better scores. While terms like "skin biopsy" were widely understood, others like "actinic" were not. Limitations include a single-center setting and limited racial diversity. Future research should focus on improving patient education and tailored communication strategies.

In this survey, investigators evaluated patients’ comprehension of frequently used cutaneous oncology-related words and looked at factors impacting their comprehension.

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.

Key Skin Cancer Terms Not Understood by Almost 1/3 of Patients Surveyed

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.

Overactive bladder is highly prevalent in women with 

, a new study reported. More than half of the sample had an overactive bladder.

“These findings support the argument that [overactive bladder] may exist only as an extension of the central sensitization process seen in fibromyalgia and not an isolated urological co-morbidity,” wrote study investigator Duygu Kurtulus, from the Ümraniye Training & Research Hospital in Turkey, and colleagues. 1“Physicians should consider routine screening for [overactive bladder] symptoms in [fibromyalgia] patients, and treatment considerations include focusing on integrated strategies where musculoskeletal and visceral symptoms are addressed together.”

Patients with fibromyalgia often experience lower urinary tract symptoms. Previous research has identified a high burden of genitourinary symptoms in fibromyalgia, but most of these studies depended on severity-oriented checklists or self-reported symptoms and did not incorporate validated, gold-standard diagnostic evaluations.

 Thus, the prevalence of urinary tract symptoms in fibromyalgia was not well-defined.

In this cross-sectional analysis, investigators evaluated how common overactive bladder is in women with fibromyalgia and compared their clinical characteristics with non-fibromyalgia controls who presented with similar urinary symptoms.

 The study included 232 women aged 18 – 65 years, with 192 diagnosed with fibromyalgia and 40 age- and symptom-matched controls.

Overactive bladder was diagnosed based on International Continence Society criteria using the Overactive Bladder Awareness Tool Version 8 (OAB-V8; cut-off ≥ 8) and a 3-day bladder diary. Fibromyalgia burden was determined via the Widespread Pain Index (WPI), Symptom Severity Scale (SSS), and the General Symptom Score (GSS). The study also recorded psychiatric comorbidities and irritable bowel syndrome (IBS).

The study identified overactive bladder in 62% of patients with fibromyalgia and 28.6% of controls (

“This discrepancy provides rigorous evidence of a substantial association between [fibromyalgia] and [overactive bladder] and indicates that urinary symptoms in [fibromyalgia] could be more than a product of random overlap between [fibromyalgia] and [overactive bladder]; they could represent a true expression of the underlying fibromyalgia-related pathophysiology,” investigators wrote.

Patients with fibromyalgia who had overactive bladder were significantly older and had longer disease duration than the controls who had overactive bladder (P <.001). These patients also had significantly greater WPI, SSS, and GSS scores than those with fibromyalgia but no overactive bladder and controls with overactive bladder (

Investigators observed moderate correlations between overactive bladder and fibromyalgia symptom severity (

Although the primary objective of this study was to assess overactive bladder prevalence in fibromyalgia, the findings also highlighted a heightened rate of co-occurring conditions among patients with fibromyalgia who experience OAB, including IBS, migraine, anxiety, depression, and obesity. The investigators noted that these comorbidities likely intensify symptom perception, contribute to shared neurochemical dysregulation, and further complicate both diagnosis and management.

The team wrote that the overlap between overactive bladder and fibromyalgia likely stems from shared neurobiological pathways, as central sensitization in fibromyalgia affects circuits involved in both pain processing and bladder sensation. Autonomic dysfunction and neurogenic inflammation further support a biological basis for their co-occurrence.

“There remains a need for a more complete understanding of the central and peripheral mechanisms by which [fibromyalgia] and [overactive bladder] are linked, and further, neuroimaging studies could provide evidence for overlap of pain and bladder circuits and autonomic profiling,” the team concluded. 

“Randomized controlled trials assessing different intervention recommendations, including pharmacological and nonpharmacological, will be integral to developing clinical treatment strategies for this complex group of patients.”

Kurtulus D, Arkan K, Suceken FY, Akgol S, Can B. Assessment of Overactive Bladder in Women With Fibromyalgia Presenting With Lower Urinary Tract Symptoms: A Controlled Clinical Study. 

Puri BK, Lee GS. Overactive Bladder Symptoms in Patients with Fibromyalgia: A Systematic Case-Controlled Study. 

A recent study highlights the high prevalence of overactive bladder (OAB) in women with fibromyalgia, suggesting it may be an extension of central sensitization rather than an isolated condition. The study found 62% of fibromyalgia patients had OAB, compared to 28.6% of controls. The research underscores the need for routine OAB screening in fibromyalgia patients and integrated treatment strategies. Shared neurobiological pathways, including central sensitization, autonomic dysfunction, and neurogenic inflammation, may explain the co-occurrence. Further research is needed to explore these mechanisms and develop effective interventions.

Evidence shows fibromyalgia patients face higher overactive bladder rates and symptom severity, highlighting the importance of integrated care.

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.

Fibromyalgia

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

High Rates of Overactive Bladder Found in Women With Fibromyalgia

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.

approved Innoviva Specialty Therapeutics’ zoliflodacin (Nuzolvence) granules for the treatment of uncomplicated urogenital gonorrhea in adults and children ≥ 12 years of age who weigh > 35 kg.

The approval builds on a December 11, 2025, approval granted to GSK for gepotidacin (Blujepa) oral tablets for adult and pediatric patients ≥ 12 years of age weighing ≥ 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of 

“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Adam Sherwat, MD, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

Zoliflodacin is a spiropyrimidinetrione antibacterial that inhibits type II topoisomerase, an enzyme essential for bacterial replication. Its novel mechanism offers an alternative to current antibiotics, addressing growing concerns about gonococcal resistance.

The approval was based on phase 3 study data which compared a single oral 3g dose of zoliflodacin with intramuscular ceftriaxone 500mg plus oral azithromycin 1g. The primary endpoint was microbiological response at the urogenital site at the Test-of-Cure visit, 6 ± 2 days after treatment. Secondary analyses included microbiological cure at rectal or pharyngeal sites and safety outcomes.

In November 2023, the phase 3 zoliflodacin trial met its primary endpoint, demonstrating statistical non-inferiority in microbiological cure at the urogenital site compared with the current global standard of care, intramuscular ceftriaxone plus oral azithromycin. The FDA granted Priority Review for zoliflodacin’s New Drug Application in June 2025.

Investigators observed that zoliflodacin demonstrated non-inferiority to ceftriaxone plus azithromycin. In the micro-intent-to-treat (micro-ITT) population (n=744), zoliflodacin achieved a microbiological cure rate of 90.9%, a 5.3% difference compared to ceftriaxone and azithromycin, which achieved a 96.2% cure rate (95% Confidence Interval [CI], 1.4%-8.7%). Microbiological cure rates at extragenital sites were comparable between treatment arms.

Zoliflodacin was generally well tolerated, and the incidence of treatment-emergent adverse events was similar between the zoliflodacin and comparison groups (46.2% vs 46.4%). Investigators did not report any deaths or other serious adverse events.

FDA. FDA Approves Two Oral Therapies to Treat Gonorrhea. December 12, 2025. Accessed December 12, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea 

Investor Relations - FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025 - Innoviva. Innoviva, Inc. Published 2025. Accessed December 10, 2025. 

https://investor.inva.com/news-releases/news-release-details/fda-grants-priority-review-zoliflodacin-new-drug-application

‌Investor Relations - Innoviva Specialty Therapeutics’ Positive Phase 3 Oral Zoliflodacin Data for the Treatment of Uncomplicated Gonorrhea Announced at ESCMID Global 2024 - Innoviva. Innoviva, Inc. Published 2024. Accessed December 10, 2025. 

https://innovivainc.gcs-web.com/news-releases/news-release-details/innoviva-specialty-therapeutics-positive-phase-3-oral

The FDA has approved Innoviva Specialty Therapeutics' zoliflodacin (Nuzolvence) for treating uncomplicated urogenital gonorrhea in individuals aged 12 and older, weighing over 77 pounds. This approval follows GSK's gepotidacin (Blujepa) approval for similar indications. Zoliflodacin, a spiropyrimidinetrione antibacterial, inhibits type II topoisomerase, crucial for bacterial replication. A phase 3 trial demonstrated zoliflodacin's non-inferiority to ceftriaxone plus azithromycin, achieving a 90.9% microbiological cure rate. The treatment was well tolerated, with similar adverse event rates compared to the standard regimen.

FDA approves zoliflodacin (Nuzolvence) for uncomplicated gonorrhea, offering a new oral treatment amid rising antibiotic resistance.

FDA Approves Zoliflodacin (Nuzolvence) Granules for Uncomplicated Urogenital Gonorrhea

Jain is the medical director of the pediatric and young adult program for hemostasis/thrombosis and sickle cell disease at Loma Linda University Children’s Health.

Videos

Jain describes the phase 3 WIL-33 trial, which marked the first test of pdVWF/FVIII in adolescent patients aged <6 years.

Conference

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Prophylaxis With von Willebrand Factor VIII Reduces Bleeding in Children, With Akshat Jain, MD, MPH

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 approval makes inebilizumab-cdon the first and only CD19-targeted B cell therapy indicated for anti-AChR and anti-MuSK Ab+ generalized myasthenia gravis.

Neurology

Neurology condition center page is a comprehensive resource for clinical news and insights on nervous system disorders. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for Alzheimer's disease, brain injury, PTSD, and more.

FDA Approves Inebilizumab-cdon (Uplizna) for Generalized Myasthenia Gravis

Berotralstat (ORLADEYO) oral granules become the first FDA-approved therapy specifically designed to prevent HAE attacks in children aged 2 – 11 years.

FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE  

The approval of a dye- and preservative-free powder formulation of trofinetide offers a new option for adult and pediatric patients with Rett syndrome.

The phase 3 DISCREET study explored the safety and efficacy of apremilast in treating patients with moderate to severe genital psoriasis over 32 weeks.

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.

Apremilast Effective Treatment for Moderate to Severe Genital Psoriasis at 32 Weeks

2025 data show the US is still failing to adequately identify and initiate care for deadly lung disease. Experts discuss what it will take to turn the tide on this public health issue.

This Year In Medicine

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.

COPD

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Lung Cancer

Getting Through the Door: How COPD, Lung Cancer Screening Remains Minimal

Weight-adjusted waist index outperforms obesity indices for cardiovascular disease prediction in cardiovascular-kidney-metabolic syndrome 


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.

Weight-Adjusted Waist Index Can Predict CVD Risk in Cardiovascular Kidney Metabolic Syndrome


What are your impressions of the Phase 2b data of zasocitinib in psoriasis, particularly in terms of Psoriasis Area and Severity Index (PASI) responses, dose-dependent effects, and tolerability? How do you see these results influencing your real-world patient selection?

Efficacy and Safety of Zasocitinib in Psoriasis and the Ideal Candidates for TYK2 Inhibitors

The panel reviews the HELIOS-B Phase 3 trial evaluating vutrisiran, a transthyretin silencer, in patients with ATTR-CM. Participants were randomized to receive vutrisiran or placebo, with approximately 40% already taking tafamidis at trial entry, particularly in the United States. The study was designed with predefined primary and secondary endpoints, assessing outcomes both in the overall population and in those not on baseline tafamidis. The trial demonstrated statistically significant results across all major endpoints, including reductions in all-cause mortality and cardiovascular hospitalizations, with notable benefit observed both in monotherapy and combination-therapy subgroups.
The panel highlights the magnitude of treatment effect and notes that these findings supported FDA approval of vutrisiran for ATTR-CM. They also emphasize its favorable safety profile, explaining that common adverse events—such as cardiac failure and arrhythmias—reflect the underlying disease rather than the drug itself. Overall, the experts describe vutrisiran as a meaningful and well-tolerated therapeutic advancement for patients with ATTR-CM.


Video Series

Evaluating Efficacy and Safety of Vutrisiran in ATTR-CM from the HELIOS-B Trial

The panelists review EADV 2025 data evaluating whether bimekizumab may help prevent PsA development in patients with psoriasis only. The study followed psoriasis patients prospectively and stratified risk using clinical factors and a patient questionnaire (PASE), treating scores <47 as low risk and ≥47 as high risk. Among patients with >1 risk factor treated with bimekizumab, over 96% maintained PASE scores <47 on longitudinal follow-up—used here as a patient-reported surrogate for not developing PsA symptoms (noting the limitation of no comparator arm). These findings align with real-world practice that prioritizes identifying high-risk patients and monitoring symptom trajectories over time. Overall, the experts interpret the stratified results as supportive—though preliminary—evidence that sustained IL-17A/F blockade may reduce transition to PsA in higher-risk psoriasis populations, while emphasizing the need for prospective, comparative data.

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