HCPLive Editorial Staff

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 lerodalcibep-liga (Lerochol) injection for adults with hypercholesterolemia, depemokimab-ulaa (Exdensur) as an add-on maintenance treatment for severe asthma, and fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, as well as Breakthrough Device Designation granted to to the Holly™ implantable, continuous dialysis system and positive topline results from a pair of phase 3 studies of zasocitinib in adults with moderate-to-severe plaque psoriasis (PsO).

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 14, 2025—let’s jump in!

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

On December 15, 2025, the FDA approved LIB Therapeutics’ lerodalcibep-liga (Lerochol) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

The novel, third-generation PCSK9 inhibitor is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability up to 3 months.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

On December 17, 2025, the FDA approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age. The decision was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials showing sustained exacerbation reduction with 2 doses per year versus placebo, both plus standard of care.

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

On December 19, 2025, the FDA approved Grifols’ fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. The product will be commercialized in the US by Grifols and is expected to be available during the first half of 2026.

FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

On December 15, 2025, the FDA granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system, recognizing Holly as a novel, transformative therapy addressing end-stage kidney disease. The designation was supported by data from a multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

On December 18, 2025, Takeda announced positive topline results from a pair of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe PsO. The Latitude studies demonstrated superiority of zasocitinib compared to placebo for the coprimary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at week 16, with a significantly greater PASI 75 response rate observed as early as week 4 and continuing to increase through week 24. Of note, the studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast.

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The FDA has approved several new treatments, including lerodalcibep-liga for hypercholesterolemia, depemokimab-ulaa for severe asthma, and fibrinogen, human-chmt for congenital fibrinogen deficiency. Additionally, the Holly implantable dialysis system received Breakthrough Device Designation, highlighting its potential in treating end-stage kidney disease. Takeda's zasocitinib showed promising results in phase 3 trials for moderate-to-severe plaque psoriasis, demonstrating significant efficacy over placebo. These developments underscore ongoing advancements in therapeutic options across various medical conditions, offering new hope for patients and healthcare providers.

Stay updated with the latest healthcare breakthroughs, including FDA news and phase 3 trial readouts, in this week's essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 12/14

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

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.

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

As 2025 comes to a close, healthcare is already being shaped by a series of high-impact developments cutting across clinical specialties.

, the ninth edition of our annual series, will reflect on the breakthroughs, challenges, and evolving conversations across healthcare. This year’s coverage will deliver a new installment every evening Monday through Friday, for the entire month of December, featuring in-depth features, expert commentary, podcasts, and dynamic multimedia content highlighting the most impactful developments in medicine from across the HCPLive Network.

This year’s series brings together perspectives on major advances across specialties, including progress in liver disease, evolving treatable traits in COPD and asthma, and continued shifts in diabetes care. Nephrology takes a central role with updates on rare kidney diseases and new insights on kidney stones, while metabolic health stays at the forefront through coverage of GLP-1 therapies reshaping cardiology, neurology, and other specialties as well as new obesity research following the latest Lancet Commission findings. 

Additional installments examine rising interest in nonhormonal options for vasomotor symptoms, renewed national attention on cancer screening after President Joe Biden’s prostate cancer diagnosis, the impact of falling vaccination rates and health misinformation, and key developments in dermatology, xenotransplantation, pulmonary screening, multiple sclerosis biomarkers, vaccine policy, and oral immunotherapy.

This edition will also feature new episodes of HCPLive’s flagship podcasts, including 

, adding expert-driven conversation to the mix.

Together, these stories and discussions carry forward the momentum of 2025 and illustrate how medicine continues to evolve as we head into 2026.

This year’s series is a collaboration across the HCPLive Network:

 on Facebook, Twitter, and LinkedIn using the hashtag 

, or follow the series on HCPLive’s homepage and daily newsletter.

A full list of entries and summaries will be available as the series unfolds. Check back throughout December for new installments and insights as we look toward 2026.

The healthcare landscape in 2025 is being shaped by significant developments across various clinical specialties. The ninth edition of "This Year in Medicine" will provide a comprehensive review of these advancements, featuring daily installments throughout December. Key areas of focus include liver disease, COPD, asthma, diabetes care, nephrology, and metabolic health. The series will also address nonhormonal treatments for vasomotor symptoms, cancer screening, vaccination rates, and health misinformation. Expert commentary and multimedia content will enhance the coverage, offering insights into the evolving field of medicine as we approach 2026.

Explore groundbreaking advancements in healthcare as 2025 concludes, featuring expert insights and dynamic multimedia. 

This Year in Medicine 2025: Recognizing Top Advances in Healthcare

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 acceptance of a supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% in children aged 2-5 years with 

 and the approval of plozasiran (Redemplo) for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome (FCS), new American Gastroenterological Association (AGA) clinical practice guidelines on the pharmacologic management of moderate-to-severely active Crohn’s disease (CD), and phase 3 data on telitacicept in IgA nephropathy and tralokinumab in adults with 

 and moderate-to-severe hand involvement.

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 November 16, 2025—let’s jump in!

FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

On November 17, 2025, the FDA accepted Arcutis Biotherapeutics’ sNDA for roflumilast (Zoryve) cream 0.3% in children 2-5 years of age with psoriasis, assigning a PDUFA target action date of June 29, 2026. The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2-5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range.

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

On November 18, 2025, the FDA approved Arrowhead Pharmaceuticals’ plozasiran (Redemplo) for the reduction of triglycerides in adult patients with FCS, making it the first and only FDA-approved siRNA medicine for people living with FCS. The decision was supported by clinical data from the phase 3 PALISADE study.

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

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

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

New phase 3 data show that in patients with IgAN at high risk of progression, treatment with telitacicept for 39 weeks resulted in a rapid, substantial, and statistically significant reduction in proteinuria compared with placebo, with a favorable safety profile. The investigational recombinant fusion protein enters a rapidly evolving therapeutic landscape in IgAN, where multiple B-cell–, BAFF-, and APRIL-targeted approaches are under active clinical investigation.

Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

On November 17, 2025, LEO Pharma A/S announced positive topline key findings on tralokinumab in adults with atopic dermatitis and moderate-to-severe hand involvement who are also candidates for systemic treatments. Findings from the 32-week analysis of the phase 3b ADHAND trial evaluating patients with atopic dermatitis and disease involvement affecting the hands build upon previous week 16 findings demonstrating statistically significant improvement compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch, and pain.

The FDA has accepted a supplemental New Drug Application for roflumilast cream for young children with psoriasis, with a decision expected by June 2026. Plozasiran has been approved for reducing triglycerides in adults with familial chylomicronemia syndrome, marking it as the first siRNA treatment for this condition. The AGA has updated its guidelines for Crohn’s disease, recommending early use of high-efficacy therapies. Telitacicept has shown significant efficacy in reducing proteinuria in IgA nephropathy. Tralokinumab has demonstrated improvements in atopic dermatitis with hand involvement in a phase 3b trial.

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