Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

The past several years have marked a clear inflection point in pulmonary arterial hypertension (PAH), with 2024 initiating a new phase of therapeutic expansion that has continued to unfold through 2025 and into 2026. After decades of incremental progress within established drug classes, the field has entered a period defined by diversification, in both mechanism and treatment strategy, reshaping how clinicians think about disease modification, escalation, and long-term management.

That shift gained momentum with landmark approvals in 2024, including sotatercept (Winrevair), the first therapy to target the activin signaling pathway, and the first once-daily fixed-dose combination of macitentan and tadalafil, marketed as Opsynvi. These approvals introduced not only new mechanisms and simplified regimens, but also a broader rethinking of how therapies can be layered earlier and more efficiently. In 2025, momentum continued with the FDA approval of inhaled treprostinil powder (Yutrepia) for PAH both alone and associated with interstitial lung disease, expanding prostacyclin therapy through a novel delivery approach designed to optimize pulmonary deposition.

As these advances accumulate, the PAH treatment landscape in 2025 and beyond reflects a growing emphasis on flexibility, durability, and individualized care. The expanding range of targets, formulations, and combinations has shifted clinical conversations toward how best to integrate newer agents alongside established pathways, how to balance efficacy with treatment burden, and how evolving evidence may redefine long-term therapeutic goals in a disease once constrained by limited options.

 in New York City, a group of pulmonologists and cardiologists led by Roxana Sulica, MD, a pulmonary medicine specialist at NYU Langone, gathered to discuss the evolving treatment field of PAH.

Throughout the forum, participants emphasized the critical importance of precise diagnosis and expert interpretation of hemodynamic data, particularly in an era where mixed or overlapping forms of pulmonary hypertension are increasingly encountered. Accurate classification, thoughtful use of right heart catheterization, and contextual interpretation of pulmonary arterial wedge pressure (PAWP) and other measurements were repeatedly highlighted as foundational to effective treatment decisions. The group agreed that while guidelines provide an essential framework, PAH management often requires nuanced clinical judgment that extends beyond algorithmic care. 

“[Treating patients] is certainly a gestalt and I always said that guidelines are guides, not replacements for the prefrontal cortex of the doctor. And it was in the 

 journal (American Journal of Respiratory Cell and Molecular Biology), that article written by cardiologists [about measuring PAWP], - the title of the article I found fabulous, is, "This Patient Needs a Doctor, Not a Guideline",” Sulica said during the forum.

:I tend to repeat more often than the guidelines say… I tend to believe the cath, and the echo more than the patient. And I did fool myself in my youth a couple of times when I believed the patient and that was the wrong- hence 90%-10% shared decision-making,” one panelist said.

The discussion also reflected a broad consensus that modern PAH treatment is moving toward earlier, more aggressive, and more comprehensive therapy. Combination regimens targeting multiple pathways, judicious use of prostacyclin therapies for higher-risk patients, and the integration of newer disease-modifying agents were all framed as part of an evolving strategy focused on preserving right ventricular function and improving long-term outcomes. 

“So you guys are OK if the patient doesn't follow-up their stuff and the drugs stop? Are you OK with that?” a panelist asked.

“If I feel like I have given them the data, the information, then it’s my responsibility to say to the patient, ‘it has to be on you, and it's important to do it, because it's dangerous to stop the medication,” another answered.

Alongside therapeutic advances, the forum highlighted persistent systemic challenges, including access to specialty care, referral delays, and care coordination, that continue to influence real-world outcomes and underscore the need for centralized expertise in PAH management.

Articles

The field of pulmonary arterial hypertension (PAH) has experienced significant advancements, particularly from 2024 to 2026, with new therapies and treatment strategies emerging. Landmark approvals, such as sotatercept and a fixed-dose combination of macitentan and tadalafil, have introduced novel mechanisms and simplified regimens. The focus has shifted towards individualized care, integrating newer agents with established pathways. A clinical forum emphasized the importance of precise diagnosis and expert interpretation of hemodynamic data, while also highlighting systemic challenges like access to specialty care and the need for centralized expertise in PAH management.

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Treat Early, Treat Hard: Redefining the Modern PAH Treatment Paradigm

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.

New research is providing clinicians with an overview of etiology-based differences in chronic pancreatitis, highlighting lower rates of serious clinical outcomes and the need for therapeutic interventions in patients with alcohol-related chronic pancreatitis (ARCP) compared to those with non-alcohol-related chronic pancreatitis (NARCP).

The study leveraged TriNetX US Collaborative Network data to create propensity score matched (PSM) cohorts for each etiology, with results highlighting lower rates of mortality, diabetes, exocrine pancreatic insufficiency, and other clinical outcomes in the ARCP group versus the NARCP group. By recognizing these differences, clinicians may be able to better optimize treatment plans, improve patient outcomes, and potentially reduce healthcare costs associated with chronic pancreatitis.

A progressive fibroinflammatory disease, chronic pancreatitis is characterized by irreversible damage to the pancreatic tissue, resulting in exocrine and endocrine dysfunction. As the disease progresses, patients often experience debilitating symptoms that significantly impact their quality of life and may develop chronic abdominal pain, malabsorption due to exocrine insufficiency, and diabetes mellitus. Due to its complex pathophysiology and varied clinical manifestations, early recognition and a comprehensive management approach are regarded as essential for improving patient outcomes.

“Understanding the different outcomes of patients with ARCP versus NARCP is essential for optimizing patient care and developing tailored therapeutic strategies,” Khaled Elfert, a gastroenterology and hepatology fellow at West Virginia University Medical School, and colleagues wrote.

To distinguish the prognosis and therapeutic needs of ARCP versus NARCP, investigators conducted a retrospective cohort study utilizing the TriNetX US Collaborative Network. Inclusion criteria were adult patients ≥ 18 years of age with a diagnosis of chronic pancreatitis. Patients were stratified into 2 groups, ARCP and NARCP, based on the documented etiology using ICD-10 codes.

Investigators employed 1:1 PSM to balance baseline characteristics between both cohorts. The primary outcome was mortality from the time of chronic pancreatitis diagnosis up to 10 years of follow-up. Secondary outcomes included exocrine pancreatic insufficiency, pseudocyst formation, development of diabetes and pancreatic cancer, and need for ERCP and celiac plexus injection.

A total of 203,432 patients with chronic pancreatitis were identified, including 11,696 with ARCP and 200,560 with NARCP. After PSM, both cohorts included 11,678 patients with nearly identical mean ages (49.9 ± 13.6 vs 49.9 ± 14.2 years) and comparable sex distributions (67.1% vs 67.6% male and 31.6% vs 31.1% female, respectively). Investigators noted racial and ethnic characteristics were also similarly balanced following matching.

After PSM, ARCP was associated with significantly lower rates of mortality (13.0% vs 16.2%; risk ratio (RR), 0.80), diabetes (22.9% vs 35.8%; RR, 0.64), exocrine pancreatic insufficiency (2.0% vs 6.1%; RR, 0.32), pancreatic cancer (1.1% vs 8.4%; RR, 0.14), and pseudocyst formation (7.1% vs 9.7%; RR, 0.73) compared to NARCP (all 

Further analysis revealed ARCP patients also had lower rates of celiac plexus injection (0.1% vs 0.8%; RR, 0.12) and ERCP (2.3% vs 10.2%; RR, 0.23) (both 

“This study highlights significant differences in the clinical outcomes and therapeutic needs of patients with ARCP and NARCP, emphasizing the value of etiology-based treatment strategies,” investigators concluded.

 “Lower rates of mortality, complications, and interventions in patients with alcohol-related disease than in those with non-alcohol-associated disease provide important insights into disease patterns that may influence prognosis and guide therapeutic decisions.”

Elfert K, Abusuliman M, Eldesouki M, et al. The Impact of Chronic Pancreatitis Etiology on Clinical Outcomes: A Population-Based Propensity-Matched Analysis. 

. 2025;18(6):269-275. doi:10.14740/gr2050

Goosenberg E, Lappin SL. Chronic Pancreatitis. StatPearls. April 4, 2025. Accessed January 7, 2026. Available from: 

https://www.ncbi.nlm.nih.gov/books/NBK482325/

New research highlights etiology-based differences in chronic pancreatitis, showing lower rates of serious clinical outcomes in alcohol-related chronic pancreatitis (ARCP) compared to non-alcohol-related chronic pancreatitis (NARCP). Utilizing TriNetX US Collaborative Network data, the study created propensity score matched cohorts, revealing lower mortality, diabetes, and exocrine pancreatic insufficiency rates in ARCP. These findings suggest that understanding these differences can help optimize treatment plans, improve patient outcomes, and reduce healthcare costs. The study emphasizes the importance of etiology-based treatment strategies for chronic pancreatitis management.

Study findings highlight the importance of etiology-based chronic pancreatitis management, with NARCP linked to worse mortality, EPI, and other clinical outcomes.

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Alcohol-Related Chronic Pancreatitis Linked to Better Outcomes Than Non-Alcohol-Related Disease

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.

The fourth and final quarter was somewhat quieter for endocrinology, but no less impactful for it. Although there were fewer regulatory updates from the 

, they carried substantial weight in the past 3 months. Between the acceptance of inhaled insulin for 

 and the approval of oral semaglutide for cardiovascular risk in T2D, the pipeline of diabetes care is promising as we enter 2026. Additionally, the American Diabetes Association released its 2026 Standards of Care, providing new guidelines for everything from GLP-1 usage to insulin pump access.

 has collected some of the most impactful headlines from Q4 of 2025 – check them out below:


FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes


On October 13, 2025, the MannKind Corporation announced the FDA’s acceptance of their supplemental biologics license application (sBLA) for human insulin inhalation powder (Afrezza) in children and adolescents living with type 1 diabetes (T1D) or type 2 diabetes (T2D). The submission was based on positive data from the phase 3 open-label INHALE-1 study, which showed the drug’s noninferiority to standard-of-care, which was multiple daily injections with basal insulin. The FDA has assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.


FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes


On October 17, 2025, the FDA approved oral semaglutide 7 mg and 14 mg (Rybelsus) for cardiovascular risk reduction in patients with T2D, irrespective of prior cardiovascular events. The approval was based on positive data from the SOUL trial, during which oral semaglutide 14 mg displayed a 14% relative reduction in major adverse cardiovascular event risk after 4 years, with a 2% reduction after 3 years, compared to placebo. The approval makes oral semaglutide the first GLP-1 to receive FDA approval in pill form.


FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism


On December 31, 2025, the FDA announced their issuance of a Complete Response Letter (CRL) in response to Corcept Therapeutics’ New Drug Application of relacorilant for hypercortisolism. Although they acknowledged that the phase 3 GRACE trial successfully met its primary endpoint, and that the subsequent GRADIENT trial provided confirming evidence, the FDA determined that it was unable to establish a favorable risk-benefit assessment without further evidence of effectiveness. According to a press release from the company, Corcept plans to meet with the FDA as soon as possible to work out a path forward.


Orforglipron Maintains Weight Loss in Patients Switching from Semaglutide or Tirzepatide


The phase 3 ATTAIN-MAINTAIN trial, the results of which were announced on December 18, 2025, saw orforglipron provide superior weight maintenance compared to placebo. A total of 376 participants who had completed the prior SURMOUNT-5 trial were enrolled and randomly assigned in a 3:2 ratio to either orforglipron maximum tolerated dose or placebo, as an adjunct to healthy diet and physical activity. Ultimately, patients switched from semaglutide to orforglipron maintained their achieved weight loss, with an average difference of 0.9 kg; those switching from tirzepatide also maintained their weight loss, with an average difference of 5 kg.


Mazdutide Demonstrates Superiority to Semaglutide in Type 2 Diabetes and Obesity


DREAMS-3, the fourth in a series of phase 3 clinical trials investigating mazdutide, proved the drug’s superiority to semaglutide in HbA1c and body weight reduction in patients with T2D and comorbid 

, according to an October 26, 2025 announcement from parent company Innovent Biologics. A total of 349 patients were enrolled in the study and randomly assigned in a 1:1 ratio to either mazdutide 6 mg or semaglutide 1 mg for 32 weeks. Ultimately, investigators recorded a -2.03% mean HbA1c change in the mazdutide arm, versus a -1.84% reduction in the semaglutide arm. Mean percentage weight reduction was logged as 10.29% in the mazdutide arm and 6% in the semaglutide arm.


SELECT: Semaglutide Indicates Possible Cardiovascular Disease-Modifying Effect


Data from the recent SELECT trial, investigating patients with atherosclerotic cardiovascular disease, suggest that semaglutide’s cardioprotective effects may be totally independent of baseline adiposity and weight loss. During the trial, semaglutide reduced major adverse cardiovascular event incidence across all baseline weight and waist circumference categories among 8803 patients in that arm. These data support the recontextualization and reconceptualization of GLP-1 receptor agonists as cardiovascular disease-modifying drugs, expanding beyond endocrinology.


Diabetes Dialogue: Therapeutic Updates from the ADA 2026 Standards of Care

, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the therapeutic side of the 2026 American Diabetes Association Standards of Care. Between new inclusion in the heart failure treatment algorithm and the first-ever recommendation for consideration in T1D and obesity, GLP-1s are still dominating the news. Expanded guidance on metabolic dysfunction-associated steatotic liver disease (MASLD/MASH) and kidney protection strategies, as well as updates to glycemic targets to normalize continuous glucose monitor usage, round out the discussion as Isaacs and Bellini encourage clinicians to engage with the guidelines and to view them as a living framework supporting comprehensive and proactive diabetes care.


Diabetes Dialogue: 2026 Technology Updates and American Diabetes Association Standards of Care


In this episode of Diabetes Dialogue, Isaacs and Bellini discuss updates from the 2026 American Diabetes Association Standards of Care, including the removal of C-peptide and autoantibody requirements as barriers to insulin pump and automated insulin delivery access. The guidelines now include a Level A recommendation for the use of automated insulin delivery in T2D, as well as updates to expand support for continuous glucose monitor usage during pregnancy beyond T1D and to reduce reliance on confirmatory fingerstick language.

The final quarter of 2025 in endocrinology saw significant FDA regulatory updates and trial results impacting diabetes care. Notable developments include the FDA's acceptance of inhaled insulin for pediatric diabetes and approval of oral semaglutide for cardiovascular risk reduction in type 2 diabetes. Trial results highlighted orforglipron's efficacy in weight maintenance and mazdutide's superiority over semaglutide in type 2 diabetes and obesity. The American Diabetes Association's 2026 Standards of Care introduced new guidelines for GLP-1 usage, insulin pump access, and continuous glucose monitoring, emphasizing comprehensive diabetes management.

The Q4 recap for endocrinology spotlights major FDA decisions, updates to diabetes care standards, and key clinical trial updates.

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Q4 2025 Recap: Endocrinology News and Updates

Pulmonology news in Q4 2025 was anchored by meaningful regulatory and clinical advances across asthma and pulmonary fibrosis, underscoring a continued shift toward longer-acting, anti-inflammatory, and disease-modifying strategies. FDA approvals of depemokimab-ulaa for severe eosinophilic asthma and nerandomilast for idiopathic pulmonary fibrosis marked major milestones for patient populations long constrained by limited therapeutic options, while emerging phase 2 data for taladegib suggested that momentum in antifibrotic development may be accelerating beyond a single new agent.

At the same time, late-2025 data and expert discussions highlighted how evolving evidence is reshaping real-world care. Label expansion of albuterol/budesonide into mild asthma, dramatic reductions in oral corticosteroid use with tezepelumab, and renewed focus on trait-based management across asthma and COPD reflected a broader effort to reduce exacerbations and treatment burden earlier in disease. Yet alongside these advances, persistent gaps in COPD and lung cancer screening served as a reminder that progress in pulmonology will depend not only on innovation, but on consistent application of tools already shown to improve outcomes.

Check out this recap of what made headlines in Q4 of 2025:

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

The FDA has approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older, introducing the first ultra–long-acting biologic in this space with twice-yearly dosing. The approval was supported by data from the phase 3 SWIFT-1 and SWIFT-2 trials demonstrating significant reductions inannualized asthma exacerbations compared with placebo while maintaining a safety profile comparable to standard of care.

Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years

The FDA has approved nerandomilast 9 mg and 18 mg (Jascayd; Boehringer Ingelheim) for adults with idiopathic pulmonary fibrosis, marking the first new IPF therapy approved in more than a decade. The decision was supported by phase 3 FIBRONEER-IPF data showing significantly reduced decline in forced vital capacity versus placebo, with a generally well-tolerated safety profile.

FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

On October 1, 2025, AstraZeneca announced FDA approval of a supplemental new drug application for albuterol/budesonide (Airsupra), expanding its indication to include adults with mild asthma. Based on results from the phase 3b BATURA trial, the therapy reduced the risk of severe exacerbations by nearly half compared with albuterol and lowered annual systemic steroid use, while maintaining a favorable safety profile. The update builds on prior evidence from the MANDALA and DENALI trials, further supporting Airsupra as the first anti-inflammatory rescue option across asthma severities.

Taladegib Shows Potential to Improve FVC in Idiopathic Pulmonary Fibrosis

Taladegib (ENV-101) demonstrated a favorable safety profile and promising signals of efficacy in a phase 2a proof-of-concept trial in patients with idiopathic pulmonary fibrosis. Treatment was associated with improvements from baseline in forced vital capacity and multiple HRCT-based measures of fibrosis, supporting further clinical development in an area of ongoing unmet need.

Tezepelumab Drastically Reduces OCS Use for Asthma in Open-Label Trial

Nearly all patients with severe, OCS-dependent asthma in the WAYFINDER trial were able to lower their daily steroid dose to 5 mg or less after 52 weeks of open-label tezepelumab, and half fully discontinued OCS while maintaining asthma control. These improvements were consistent across inflammatory subgroups, though the absence of a control arm makes the magnitude of benefit harder to interpret.

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management

In this HCPLive expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

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

Despite well-established screening tools and expanded eligibility criteria, COPD and lung cancer remain profoundly underdiagnosed in the US, with most patients still identified at advanced stages when survival benefits are limited. Experts point to systemic access gaps, clinician hesitation, and persistent disease stigma as key barriers, underscoring that improving outcomes in 2026 will depend less on new technology than on using the tools already proven to work.

Q4 2025 in pulmonology was marked by significant regulatory and clinical advancements in asthma and pulmonary fibrosis, emphasizing a shift towards longer-acting, anti-inflammatory, and disease-modifying treatments. Notable FDA approvals included depemokimab-ulaa for severe eosinophilic asthma and nerandomilast for idiopathic pulmonary fibrosis, offering new options for patients with limited therapies. Emerging data for taladegib indicated progress in antifibrotic development. Despite these advances, gaps in COPD and lung cancer screening highlighted the need for consistent application of existing tools to improve outcomes.

The Q4 recap for pulmonology spotlights regulatory and clinical advances across asthma and pulmonary fibrosis.

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Q4 2025 Recap: Pulmonology News and Updates

Image Credit: US Food and Drug Administration

Announced by parent company Octapharma USA, Inc., on January 7, 2026, the 

 has approved a 2-gram presentation of Fibrinogen (Human) Lyophilized Powder for Reconstitution (Fibryga) for fibrinogen replacement in patients with 

Initially approved as a 1-gram single-dose bottle in 2024, Fibryga is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for AFD in the US. Its lyophilized powder formulation allows it to rapidly reconstitute at the point of care, offering a more direct and consistent alternative to cryoprecipitate. This updated kit also contains 100 mL of Water for Infusion (WFI) and continues to feature the nextaro reconstitution device.

“The introduction of the 2-gram Fibryga kit is a direct response to the needs of clinicians managing critical bleeding,” Flemming Nielsen, president of Octapharma USA, said in a statement. “By simplifying preparation and expanding dosing flexibility, we’re helping providers act faster and more precisely – when every second counts.”

Fibryga’s initial FDA approval was based on positive results from the landmark FIBRES study, a multicenter randomized clinical trial investigating patients undergoing cardiac surgery and requiring fibrinogen replacement due to significant bleeding related to acquired hypofibrinogenemia. Investigators in FIBRES aimed to determine the noninferiority of fibrinogen concentrate to the standard-of-care treatment cryoprecipitate, as measured by the amount of allogeneic blood components administered, including red cells, platelets, and plasma.

Patients were eligible for inclusion if they were undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) and had fibrinogen supplementation ordered by clinicians in response to post-CPB hemorrhage in the presence of confirmed or suspected acquired hypofibrinogenemia. Patients were excluded if they had received fibrinogen concentrate or cryoprecipitate within 24 hours prior to surgery or had a history of severe allergic reaction to either drug, among other criteria.

A total of 15,412 patients underwent cardiac surgery at the 11 participating sites – of these, 725 were screened and randomly assigned in a 1:1 ratio to either 4g fibrinogen concentrate, infused over roughly 10 minutes (n = 372), or 10 units cryoprecipitate, infused according to local practice (n = 363). Patients only received the allocated product for 24 hours after CPB, after which only cryoprecipitate was used.

Ultimately, mean allogeneic blood component units administered were 16.7 units (standard deviation [SD], 16.4) within 24 hours after termination of CPB and 22.4 units (SD, 23.1) from beginning of surgery to postoperative day 7. Mean 24-hour post-bypass cumulative allogeneic blood component transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate arm and 17 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group. The mean ratio was 0.96 (1-sided 97.5% CI, -∞ to 1.09; 

 <.001 for noninferiority; 2-sided 95% CI, 0.84 to 1.09; 

Investigators also recorded noninferiority for the secondary outcomes of individual 24-hour and cumulative 7-day blood component transfusions, as well as in a post hoc outcome of cumulative transfusions measured from product administration to 24 hours after termination of CBP (mean units, 8.6 [95% CI, 7.5 to 9.9] in fibrinogen concentrate versus 8.9 [95% CI, 7.8 to 10.2] in the cryoprecipitate group; mean ratio, 0.97 [1-sided 97.5% CI, -∞ to 1.13; 

Fibryga is now approved for fibrinogen supplementation in both congenital and acquired fibrinogen deficiency and is available in 1-gram and 2-gram kits, both of which use the nextaro device.

“Octapharma continues to invest in innovations that improve outcomes for patients with serious bleeding complications,” Huub Kreuwel, PhD, vice president of medical affairs at Octapharma USA, said in a statement. “The new 2-gram Fibryga kit is another step forward in our mission to redefine the standard of care in hemeostasis.”

Octapharma USA, Inc. FDA Approves New 2-Gram Presentation of Fibryga, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency. 

. January 7, 2026. Accessed January 7, 2026. 

https://prnmedia.prnewswire.com/news-releases/fda-approves-new-2-gram-presentation-of-fibryga-enhancing-convenience-and-precision-in-treating-acquired-fibrinogen-deficiency-302654022.html

Callum J, Farkouh ME, Scales DC, et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery. JAMA. 2019;322(20):1966. 

Karkouti K, Callum J, Rao V, et al. Protocol for a phase III, non-inferiority, randomised comparison of a new fibrinogen concentrate versus cryoprecipitate for treating acquired hypofibrinogenaemia in bleeding cardiac surgical patients: The fibres trial. BMJ Open. 2018;8(4). 

The FDA has approved a 2-gram presentation of Fibryga, a virus-inactivated, human plasma-derived fibrinogen concentrate, for treating acquired fibrinogen deficiency (AFD). This new formulation offers rapid reconstitution and improved dosing flexibility, enhancing treatment precision for critical bleeding. The approval follows the FIBRES study, which demonstrated Fibryga's noninferiority to cryoprecipitate in reducing allogeneic blood transfusions during cardiac surgery. Fibryga is now available in both 1-gram and 2-gram kits, supporting its use in both congenital and acquired fibrinogen deficiencies.

This updated approval builds on the success of Fibryga’s 2024 approval for AFD, which was based on positive data from the phase 3 FIBRES trial.

Hematology

FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

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.

Retrospective data suggest serum creatinine trajectories might predict 28-day mortality in acute kidney injury on chronic kidney disease. 


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Serum Creatinine Trajectories May Predict 28-Day Mortality in CKD

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.

A study found no differences in depressive symptom reduction when nonresponders continued therapy, switched therapists, or changed both therapist and treatment approach.

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Switching Therapists for Psychotherapy Offers No Advantage in MDD

Catch up on IBD steroid exposure risk, intensive weight loss before colorectal cancer surgery, a new chronic idiopathic constipation treatment option, and more.

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Strategic Alliance Partnership

5 Gastroenterology Headlines You Missed in December 2025

Johnson & Johnson plans to initiate a phase 3 study based off the positive data.

Lupus

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Nipocalimab Reduces SLE Disease Activity, Meeting JASMINE Study End Point

Amer Zeidan, MD, is a professor of medicine and the chief of the Division of Hematologic Malignancies at Yale University.

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Zeidan discusses the interim results from the ongoing phase 1/2 trial, highlighting bexmarilimab’s efficacy in combination with azacitidine SoC.

Bexmarilimab Safe and Efficacious in Treating Myelodysplastic Syndromes, With Amer Zeidan, MD

A cross-sectional study in CKD suggests patients undergoing hemodialysis have increased social frailty and depression compared to transplant recipients. 


Chronic Kidney Disease Paired With Social Frailty May Increase Depression Risk  

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.

Two phase 3 trials met their primary and secondary endpoints in patients with moderate-to-severe plaque psoriasis on envudeucitinib.

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ONWARD Studies: Oral Envudeucitinib Treatment Effective, Safe for Psoriasis

Crohn’s & Colitis Foundation survey findings show 18% of young adults with IBD work extra hours to afford care and > 1 in 3 are not confident navigating insurance.

Young Adults With IBD Face Greater Healthcare Access Challenges, Financial Burdens

Alixorexton receives FDA Breakthrough Therapy Designation, promising significant advancements in treating narcolepsy type 1.

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FDA Grants Breakthrough Therapy Designation to Alixorexton for Narcolepsy Type 1

Sonalika Khachikian, MD, is an endocrinologist at Monument Health.

Timely referral and accurate assessment of disease activity and severity are critical determinants of outcomes in thyroid eye disease (TED) management.

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