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.

December saw significant progress in the hematology space, marked by key trial results at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, as well as a number of 

 approvals. Mitapivat and narsoplimab received approvals for 

 in alpha- or beta-thalassemia and hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), respectively. At the same time, roxadustat was granted Orphan Drug Designation for myelodysplastic syndromes. Meanwhile, new data from the XTEND-ed trial and the LUNA 3 long-term extension provided key insights into the efficacy of efanesoctocog alfa and rilzabrutinib.

In light of this sudden influx of news, the editorial team at 

 has collected 11 of the most impactful headlines from December to make catching up a bit easier. Check them out below.

FDA Approves Fibrinogen, Human-chmt (Fesilty) for Congenital Fibrinogen Deficiency


On December 19, 2025, the FDA approved fibrinogen, human-chmt under the brand name Fesilty for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. The human blood coagulation factor has now received regulatory approval in 2 countries and is expected to receive approval across European markets in 2026. Additionally, parent company Grifols expects Fesilty to be available during the first half of 2026.


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

On December 8, 2025, the FDA approved omidubicel-onlv, making it the first approved hematopoietic stem cell transplant therapy for severe aplastic anemia and addressing a patient population with critically unmet medical need. Omidubicel-onlv functions via donated cord blood stem cells chemically enhanced with nicotinamide, which are given to a patient to restore the blood and immune system. It addresses limitations of umbilical cord blood as a source, including delayed hematopoietic recovery and increased infections. It also provides additional graft options for patients who need hematopoietic stem cell transplant.


FDA Grants Orphan Drug Designation to Roxadustat for Myelodysplastic Syndromes


On December 15, 2025, the FDA granted Orphan Drug Designation to FibroGen’s roxadustat for the treatment of myelodysplastic syndromes. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor stimulates erythropoiesis by increasing endogenous erythropoietin production, enhancing iron absorption and mobilization and suppressing hepcidin. The decision was based on a post-hoc analysis of the phase 3 MATTERHORN trial, which displayed roxadustat’s association with greater transfusion independence compared to placebo in patients with high baseline transfusion burdens.


FDA Approves Narsoplimab (Yartemlea) As First TA-TMA Therapy


On December 24, 2025, the FDA approved Omeros Corporation’s narsoplimab-wuug – under the brand name Yartemlea – for the treatment of hematopoietic stem cell TA-TMA. This decision makes narsoplimab the first and only approved lectin pathway inhibitor in TA-TMA care. Results from a single-arm, open-label study and additional data from an expanded access program formed the backbone of the application; during these trials, narsoplimab treatment resulted in a 3- to 4-fold reductions in mortality risk compared with an external control cohort. Particularly of note, narsoplimab has no Boxed Warning and no Risk Evaluation and Mitigation Strategy, and vaccinations are not required before treatment.


FDA Approves Mitapivat (AQVESME) for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia

On December 24, 2025, the FDA approved mitapivat, an oral activator of pyruvate kinase R, developed by Agios for the treatment of anemia in adults with alpha- or beta-thalassemia, a disease with historically few treatment options. The decision was based on the phase 3 ENERGIZE and ENERGIZE-T trials, both of which saw mitapivat recipients exhibit substantial hemoglobin response after treatment compared to placebo.


SUMMIT: Bezuclastinib Outperforms Placebo in Nonadvanced Systemic Mastocytosis


Data from the registration-directed part 2 of the phase 2 SUMMIT trial, presented at the 67

 ASH meeting, showcased bezuclastinib’s benefits on patient-reported symptoms and objective measures of mast cell burden in patients with nonadvanced systemic mastocytosis (NonAdvSM). The trial enrolled a total of 179 patients; among these, 119 received bezuclastinib and 60 received placebo. By week 24, patients receiving bezuclastinib saw a substantial reduction of serum tryptase, while placebo recipients saw none.


Ianalumab Improves Stable Response, Reduces Fatigue in ITP, With Hanny Al-Samkari, MD


A presentation of the VAYHIT2 trial at ASH 2025 by Hanny Al-Samkari, MD, the Peggy S. Blitz Endowed Chair in hematology and oncology at the Massachusetts General Hospital, has shown ianalumab’s efficacy in prolonging time to treatment failure in patients with primary immune thrombocytopenia when combined with eltrombopag. Additionally, ianalumab improved stable response at 6 months, reduced fatigue, facilitated tapering off eltrombopag, and delayed the need for subsequent therapy.


VAYHIT3: Ianalumab Reduces Bleeding, Depletes B Cells in Immune Thrombocytopenia, With Philip Choi, MBBS, PhD


A secondary analysis of the VAYHIT3 trial, presented at ASH 2025 by Philip Choi, MBBS, PhD, an associate professor at the Australian National University College of Science and Medicine, highlighted ianalumab’s rapid reduction in bleeding events and B-cell depletion in patients with primary immune thrombocytopenia in heavily pretreated adults. A series of biomarker analyses are expected over the next 12-18 months.


HOPE-B: 5-Year Etranacogene Dezaparvovec Maintains Durable Efficacy and Safety in Hemophilia B, With Steven Pipe, MD

Presented by Steven Pipe, MD, professor of pediatrics and pathology at the University of Michigan, at ASH 2025, an analysis from the HOPE-B trial has shown that a single dose of etranacogene dezaparvovec maintains durable endogenous factor IX Padua expression and produces sustained reductions in bleeding rates in adult patients with moderately severe or severe hemophilia B, with ≤90% reduction by year 5. The adeno-associated virus vector-based one-time gene therapy received FDA approval in 2022 as the first gene therapy for adults with hemophilia B who use factor IX prophylaxis with current or prior life-threatening bleeding. Participants from the HOPE-B trial who have given consent will continue long-term monitoring for up to 15 years in the IX-TEND 3003 study.


Rilzabrutinib Preserves Platelet Response in ITP Through Extension Study, With David Kuter, MD

Data from the LUNA 3 trial, presented by David Kuter, MD, the director of clinical hematology at Massachusetts General Hospital, at ASH 2025, have shown rilzabrutinib’s capacity for sustained platelet responses and symptom improvement in patients with immune thrombocytopenia. This allowed patients enrolled in the trial to wean off of concomitant corticosteroids while maintaining platelet counts within a safe range. Additionally, median platelet counts stayed relatively consistent through an extension period of 33 months.


Efanesoctocog Alfa Improves Bleeding Regardless of Age in Hemophilia A, With Lynn Malec, MD, MSc

The XTEND-ed study, presented by Lynn Malec, MD, MSc, an associate professor in the division of hematology and oncology at the Medical College of Wisconsin, at ASH 2025, displayed efanesoctocog alfa’s tolerability and efficacy in providing bleed protection to adult, adolescent, and child patients with severe hemophilia A. This first-in-class high-sustained factor VIII replacement therapy decouples recombinant FVIII from endogenous von Willebrand factor, resulting in substantially reduced risk of spontaneous and traumatic bleeds.

Articles

December marked significant advancements in hematology, highlighted by pivotal trial results and FDA approvals. Mitapivat and narsoplimab received approvals for anemia in thalassemia and TA-TMA, respectively, while roxadustat gained Orphan Drug Designation for myelodysplastic syndromes. The FDA also approved Fesilty for congenital fibrinogen deficiency and omidubicel-onlv for severe aplastic anemia. Key trials, including SUMMIT, VAYHIT2, and HOPE-B, demonstrated promising outcomes for treatments like bezuclastinib, ianalumab, and etranacogene dezaparvovec, offering new insights into managing hematological conditions.

Catch up with major FDA decisions, critical conference news, and more.

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FDA News

11 Hematology Headlines You Missed in December 2025

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

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? 

Top 5 Healthcare Headlines for December 28-January 3, 2025:

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

The FDA granted 510(k) clearance to StimLabs’ Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation.

FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion

The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting.

FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism

The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials.

FDA Issues Complete Response Letter for ONS-5010 for Wet AMD

The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application.

FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation

The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer’s disease.

The recent healthcare updates include significant FDA actions impacting various treatments. The FDA granted 510(k) clearance to StimLabs’ Theracor, the first umbilical cord–derived wound care device in sheet form. Tradipitant received approval as a new option for preventing motion sickness–related vomiting. However, the FDA issued complete response letters for relacorilant for hypercortisolism and ONS-5010 for wet AMD, citing the need for more evidence. Meanwhile, AXS-05's sNDA for Alzheimer's disease agitation received Priority Review, indicating potential advancement in treatment options.

An audio recap of the top 5 stories in healthcare news from the week of 12/28-1/3.

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HCPLive 5 Stories in Under 5: Week of 12/28

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.

Audrey Lasek, MD
Credit: Group Des Hôpitaux Université Catholique De Lille

Dupilumab’s efficacy and safety findings among children aged 6 months to 5 years with 

 are consistent with previous results observed in those with moderate-to-severe disease, new data suggest.

Audrey Lasek, MD, from the Group Des Hôpitaux Université Catholique De Lille, led a team of investigators in authoring this analysis. Lasek and colleagues noted authorization in France for early access to medications allows patients to be treated with investigational drugs or foreign medicines. It can also allow for access to approved treatments for unapproved indications prior to formal European Medicines Agency (EMA) approvals via the pre-marketing authorization Early Access Program (EAP).

This system, Lasek and coauthors highlighted in the background portion of their analysis, allows for more timely options for medication among patients with 

 and addresses gaps in drug availability.

“This study reports aggregated data from the French EAP, evaluating the effectiveness and safety of dupilumab treatment in children aged 6 months–5 years with severe [atopic dermatitis] in a real-world setting prior to dupilumab reimbursement in France,” the investigators wrote.

There were 108 physicians involved in this expanded access program in France, with infants and young children aged 6 months to 5 years with severe atopic dermatitis being enrolled by these clinicians through 65 clinical sites located across the country. Nearly all of the participating centers were public institutions.

Lasek et al noted 96.9% of the 65 sites were public hospitals and only 2 sites (3.1%) were private healthcare facilities. Individuals deemed eligible met the investigators' predefined criteria, including having a dermatologist-confirmed atopic dermatitis diagnosis, requiring systemic drugs, and having an inadequate response to, intolerance of, or contraindication to the use of topical corticosteroids.

A mix of secondary care centers were used in this program, along with university hospitals, general hospitals, and a small number of private centers. University hospitals made up the majority of sites taking part (72.2%). Prescribing authority was restricted to specialists who were hospital-based and working in allergology, dermatology, or internal medicine.

Several patient populations were defined within the program, including all of those for whom an EAP request was provided, subjects who were formally involved and granted treatment based on criteria for eligibility, and exposed patients who received at least 1 dupilumab dose and provided at least a single initiation, follow-up, or drug cessation form and a documented administration date.

Dupilumab was administered by Lasek and colleagues subcutaneously on an every-4-week basis, with prefilled syringes being implemented. They used a dose of 200 mg for children weighing 5 kg at least but less than 15 kg. Alternatively, a 300 mg syringe would be given to those weighing at least 15 kg but less than 30 kg, in alignment with protocol recommendations. Children who initially weighed under 15 kg but attained this threshold in the middle of the program would be kept on the 200-mg dosing regimen throughout their participation.

The investigative team looked at clinical effectiveness via multiple validated outcome measures. Such measures included the Investigator’s Global Assessment, the Pruritus Numerical Rating Scale, Eczema Area and Severity Index (EASI) with 50%, 75%, and 90% improvement thresholds, and age-appropriate quality-of-life instruments.

Lasek and coauthors used the Infants’ Dermatitis Quality of Life Indexfor childr en who were younger than 4 years of age. They would apply the Children’s Dermatology Life Quality Index to those aged 4 years or older. Evaluations were performed at the point of baseline and at the 1, 3, and 6-month marks. Safety was monitored throughout the study period.

Dupilumab Results in Children with Severe Atopic Dermatitis

There were 198 children recruited within the analysis, with 13.6% being under 2 years of age 86.5% being aged 2 years or older. Notably, among the 116 individuals evaluated by Lasek et al who had at least a single follow-up examination, substantial clinical improvements were seen by the 6-month mark.

94.4%, 75.0%, and 44.4% of subjects in the study met EASI 50, EASI 75, and EASI 90 response criteria, respectively. The investigators also found IGA score attainment of 0 or 1 was seen among 83.7% of those assessed. Additionally, the investigative team found 67.6% of participants reported at least a 4-point reduction in pruritus severity as determined by the P-NRS.

Lasek and the team further noted, from treatment initiation to Month 6, study subjects' mean ± standard deviation reductions were shown to be −17.5 ± 11.6 for EASI, −2.1 ± 1.2 for IGA, and −4.4 ± 2.8 for P-NRS scores. Outcomes related to patients' quality-of-life also improved over the same period, with the team highlighting mean ± SD decreases of −6.9 ± 6.6 in participants' IDQOL scores and −8.8 ± 7.3 in their CDLQI scores.

The investigators' safety findings during the program were also found to have been in line with the previously established safety profile of dupilumab in both pediatric and adult patients with atopic dermatitis.

“The real-world nature of the EAP complements the controlled environment of randomized clinical trials, offering insights into the practical use of dupilumab in routine clinical practice, in children as young as 6 months old,” the team concluded.

 “A longer term follow-up is required to assess the durability of response and long-term safety of dupilumab in this young population.”

Lasek A, Bellon N, Achour L, et al. Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis. J Eur Acad Dermatol Venereol. 2025; 00: 1–10. 

Tarantola A, Otto MH, Jommi C, et al. Early access programs for medicines: comparative analysis among France, Italy, Spain, and UK and focus on the Italian case. J Pharm Policy Pract. 2023 May 17;16(1):67. 

Dupilumab has shown consistent efficacy and safety in children aged 6 months to 5 years with severe atopic dermatitis, aligning with previous findings in older populations. The study, conducted under France's Early Access Program, involved 198 children and demonstrated significant clinical improvements by the 6-month mark. The program allowed for timely access to dupilumab before formal EMA approval. The study highlighted substantial improvements in EASI, IGA, and pruritus scores, with safety outcomes consistent with established profiles. Long-term follow-up is needed to assess the durability of response and safety.

The data may help to guide informed decision-making related to dupilumab use and management of severe atopic dermatitis in infants and young children.

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.

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Dupilumab Effective for Children with Severe Atopic Dermatitis in Real World Setting

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.

December 2025 capped a transformative year in 

 and immunology, with late-breaking regulatory decisions, pivotal trial results, and emerging clinical insights reinforcing the rapid pace of change across the field. This month in review highlights key developments shaping day-to-day practice, including new and forthcoming therapies for hereditary angioedema (HAE), advances in food allergy management, and data that further refine treatment selection and patient counseling.

For clinicians, December’s updates underscore a broader shift toward more personalized, less burdensome care, particularly for pediatric and multi-allergic populations, while setting the stage for continued innovation heading into 2026.

FDA Approved Another HAE Treatment on December 12th

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

The US Food and Drug Administration (FDA) has approved berotralstat (ORLADEYO) oral granules for children aged 2 to 11 years with HAE, marking the first FDA-approved oral prophylactic therapy designed for this pediatric population. Announced by BioCryst Pharmaceuticals, the approval addresses a longstanding treatment gap for children under 12. The decision was supported by positive interim data from the APeX-P trial, demonstrating sustained reductions in HAE attack rates and a safety profile consistent with adults. Experts from institutions, including UCLA, highlighted the reduced treatment burden compared with injectable therapies, expanding long-term management options for pediatric HAE.

Pharvaris’ Deucrictibant Provides Rapid Relief for HAE in Phase 3 RAPIDe-3 Trial

Pharvaris’ oral bradykinin B2 receptor antagonist deucrictibant met its primary endpoint in the phase 3 RAPIDe-3 trial, providing rapid relief of HAE attacks in under 90 minutes. In the global, placebo-controlled study of 134 patients aged ≥ 12 years, deucrictibant significantly shortened time to symptom onset, substantial relief, and complete resolution versus placebo. Most attacks were controlled with a single 20-mg dose, and > 93% required no rescue medication. The therapy was well tolerated, with no treatment-related serious adverse events. Pharvaris plans to submit a New Drug Application (NDA) to the FDA in 2026.

Allergy Field Spotlights from Our This Year in Medicine Series

A New Era in Food Allergy Treatment: The Push Toward Multi-Allergen Immunotherapy

Food allergy care is entering a new phase as clinicians push toward therapies that address multiple allergens simultaneously. Following the FDA approval of omalizumab (Xolair) in 2024, experts report meaningful quality-of-life improvements for patients with multiple food allergies by increasing reaction thresholds, though it is not curative.

With food allergy prevalence up 50% since the 1990s, 2025 research highlighted renewed interest in multi-allergen oral immunotherapy (OIT), including investigational ADP101, and growing momentum for sublingual immunotherapy. Despite mixed trial results, clinicians see promise in raising thresholds across several foods. With evolving prevention strategies and new devices, these advances signal a shifting landscape in food allergy management.

Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

Before berotralstat, the FDA approved 3 other new HAE therapies—garadacimab-gxii (Andembry), sebetralstat (Ekterly), and donidalorsen (Dawnzera)—marking a major expansion in treatment options for this rare genetic disease. Experts from UCLA Health and the University of Colorado highlighted how these approvals enable more personalized care through novel mechanisms, oral and injectable options, and less frequent dosing.

Despite this rapid progress, clinicians emphasized persistent unmet needs, particularly for pediatric patients under 12 years and for therapies that improve portability and access. Overall, the 2025 approvals signal a turning point in HAE management and research momentum.

As 2025 came to an end, we put together a year-in-review that reflects the most impactful developments that shaped allergy and immunology over the past 12 months. From landmark FDA approvals to pivotal trial readouts and evolving clinical guidance, 2025 marked a period of accelerated progress across both rare and common allergic diseases.

Breakthroughs in HAE expanded preventive and on-demand options, while advances in food allergy prevention, immunotherapy, and anaphylaxis management influenced everyday clinical practice. These highlights capture a year defined by therapeutic innovation, growing personalization of care, and meaningful shifts in how clinicians approach allergy management across the lifespan.

December 2025 marked significant advancements in allergy and immunology, with pivotal regulatory decisions and trial results shaping clinical practice. Key developments included FDA approval of berotralstat for pediatric hereditary angioedema (HAE), promising phase 3 results for deucrictibant, and progress in multi-allergen immunotherapy for food allergies. These updates highlight a shift towards personalized, less burdensome care, especially for pediatric and multi-allergic populations. The year concluded with a focus on therapeutic innovation and evolving strategies in allergy management, setting the stage for continued progress in 2026.

December highlights: FDA approval of berotralstat for pediatric HAE, phase 3 RAPIDe-3 results, and allergy field spotlights in our This Year in Medicine series.

Allergy

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5 Allergy Headlines You Missed in December 2025

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 (FDA) 510(k) clearance of StimLabs’ Theracor for wound care, the approval of tradipitant (Nereus) for motion sickness, Complete Response Letters (CRL) for Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration, and the acceptance and Priority Review of Axsome Therapeutics’ supplemental New Drug Application for AXS-05 for the treatment of agitation in Alzheimer’s disease.

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 28, 2025—let’s jump in!

On December 29, 2025, the FDA granted 510(k) clearance to StimLabs’ Theracor, the first human umbilical cord–derived medical device offered in a sheet formulation. The clearance builds upon the Agency’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.

On December 30, 2025, the FDA approved Vanda Pharmaceuticals’ tradipitant under the brand name Nereus for the prevention of vomiting induced through motion sickness. The decision marked the first new pharmacologic treatment in motion sickness in more than 4 decades and was based on data from a pair of phase 3 trials, Motion Syros and Motion Serifos, showing lower vomiting and severe nausea with tradipitant versus placebo.

On December 31, 2025, the FDA issued a CRL to Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism. While the Agency acknowledged the GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence, the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.

On December 31, 2025, the FDA issued a CRL to Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration. The latest CRL adds to 2 previous CRLs in ONS-5010’s lengthy regulatory road, with the FDA determining that the additional mechanistic and natural history data provided in the newest resubmission failed to alter the previous review conclusion, which stated that confirmatory evidence of efficacy must be submitted to support the application. At the time of the CRL, the FDA had not yet indicated what type of confirmatory evidence would be acceptable.

On December 31, 2025, the FDA accepted and granted Priority Review to Axsome Therapeutics’ supplemental New Drug Application (sNDA) for AXS-05 for the treatment of agitation in Alzheimer’s disease, setting a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. The sNDA was supported by data from the comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation, including 4 randomized, double-blind, controlled phase 3 clinical trials and a long-term safety trial.

Hillenbrand A. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care. HCPLive. December 29, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-grants-510-k-clearance-first-umbilical-cord-derived-sheet-formulation-wound-care

Livingston R. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-approves-tradipitant-nereus-for-the-prevention-of-vomiting-induced-by-motion

Livingston R. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-issues-complete-response-letter-for-relacorilant-for-hypercortisolism

Livingston R. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-issues-complete-response-letter-for-ons-5010-for-wet-amd

Livingston R. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-accepts-grants-priority-review-to-axs-05-snda-for-alzheimer-s-disease-agitation

The FDA has granted 510(k) clearance to StimLabs’ Theracor, a novel umbilical cord-derived sheet for wound care. Tradipitant, branded as Nereus, received FDA approval for motion sickness, marking the first new treatment in over 40 years. Corcept Therapeutics’ relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for wet AMD both received Complete Response Letters, requiring additional evidence. Axsome Therapeutics’ AXS-05 for Alzheimer’s agitation was accepted for Priority Review, with a target action date set for April 30, 2026.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and CRLs, in this week’s essential news roundup.

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The HCPFive: Top News for Healthcare Providers from the Week of 12/28

A recent retrospective cohort analysis of the ACCORD phase 3 study has revealed a correlation between higher index values and increased mortality risk.

Type 2 Diabetes

Weight-Adjusted Waist Index Predicts Cardiovascular Risk in Patients with T2D

This FDA News Month in Review provides a round-up of regulatory decisions from December 2025.

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10 FDA Headlines You Missed in December 2025

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

Rheumatoid Arthritis

The HCPLive rheumatoid arthritis page is a comprehensive resource for clinical news and insights on arthritis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for RA, and more.

Rheumatoid Arthritis in 2025: Year in Review

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

Endocrinology in 2025: Year in Review

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Podcasts

Cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the groundbreaking news of oral semaglutide's approval and its cardioprotective benefits. 

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

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Diabetes Dialogue: Breaking New Ground With Oral GLP-1s in Cardiology and Weight Loss

Investigators conducted a network meta-analysis comparing and ranking the safety and efficacy of dietary supplements as adjunctive therapy for patients with psoriasis.

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.

Dietary Supplements Aid in Psoriasis Treatment, Though Effect Estimates Vary

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.

In December 2025, intervention strategies, dialysis modalities, and kidney transplantation data provided insight to improve renal care for clinicians. 


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.

6 Nephrology Headlines You Missed in December 2025

Sophia Thomas, DNP, APRN, FNP-BC, PPCNP-BC, FAANP, FNAP, FAAN, former president of the American Association of Nurse Practitioners and nurse practitioner at DePaul Community Health Centers

Nurse practitioners play a key role in allergy and asthma care using specific IgE blood testing to identify triggers, improve outcomes, and ease shortages.

Seasonal Allergy

Understanding Allergies from Bedside to Blood Test

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Videos

Summary of the phase 3b APEX study showing guselkumab’s efficacy and inhibition of structural joint damage.

Latest News

11 Hematology Headlines You Missed in December 2025

HCPLive 5 Stories in Under 5: Week of 12/28

Dupilumab Effective for Children with Severe Atopic Dermatitis in Real World Setting

5 Allergy Headlines You Missed in December 2025

The HCPFive: Top News for Healthcare Providers from the Week of 12/28