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 back to our recap of this month's news and updates from the 

In January 2026, the FDA issued a series of approvals and regulatory updates spanning rare hematology, neurology, endocrinology, respiratory, and ophthalmology care. Highlights include the approval of caplacizumab-yhdp (Cablivi) for pediatric aTTP, marking the first approved therapy for children with this life-threatening disorder, and the expansion of Octapharma’s Fibryga kit to a 2-gram presentation for acquired fibrinogen deficiency, improving dosing flexibility in critical bleeding. In endocrinology, the FDA requested removal of suicidal ideation warnings from GLP-1 receptor agonist labeling after extensive safety reviews found no increased risk, while in mental health, ProlivRx became the first at-home neuromodulation therapy for adults with major depressive disorder, demonstrating improved remission rates in the MOOD trial.

Additional highlights in January 2026 include the approval of new discreet packaging for OTC Narcan to increase carry rates and readiness in opioid emergencies, 510(k) clearance of LEADOPTIK’s Last Inch Assessment™ system to enhance lung biopsy accuracy with integrated high-resolution imaging, and Tenpoint Therapeutics’ YUVEZZI, the first fixed-dose dual-agent eye drop for presbyopia, which improved near vision by ≥3 lines in pivotal trials without compromising distance acuity. Here’s a concise overview of the key FDA decisions and updates from January 2026.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Treatment for Pediatric aTTP

On January 5, 2026, the FDA approved Sanofi’s caplacizumab-yhdp (Cablivi) for use in pediatric patients aged ≥12 years with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. The decision expands caplacizumab’s 2019 adult indication and makes it the first approved therapy specifically for pediatric aTTP, a rare and life-threatening disorder. Approval was supported by data from a retrospective chart review of 30 patients aged 2–18 years, in which 80% achieved clinical remission, defined by sustained normalization of platelet counts and LDH levels. 

2. FDA Approves 2-Gram Fibryga Kit for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a new 2-gram presentation of Octapharma’s fibrinogen (human) lyophilized powder for reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. The expanded presentation builds on Fibryga’s 2024 approval as the first and only virus-inactivated, plasma-derived fibrinogen concentrate approved for this indication in the US and is designed to improve dosing flexibility and speed of administration in critical bleeding settings. 

3. FDA Requests Removal of Suicidal Ideation Risk From GLP-1 RA Labels

On January 13, 2026, the FDA requested the removal of language describing a potential risk of suicidal ideation and behavior from the labeling of select GLP-1 receptor agonists, including liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound), following a comprehensive safety review. Based on meta-analyses of more than 100,000 patients and large real-world studies, the Agency found no evidence of increased risk for suicidal ideation, self-harm, or other psychiatric adverse events associated with GLP-1 RA use.

4. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The FDA has approved ProlivRx, the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded to at least one antidepressant, enabling supervised treatment outside of clinic settings. Approval was supported by the MOOD trial, in which ProlivRx significantly improved remission rates versus sham and demonstrated a favorable safety profile, positioning it as a new nonpharmacologic option for difficult-to-treat depression.

5. FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

The FDA has approved new discreet carrying-case packaging for OTC Narcan (naloxone) nasal spray to improve portability, reduce stigma, and encourage everyday carry. The update addresses persistently low preparedness, as only 10% of the general population reports carrying naloxone despite its OTC availability.

6. FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy

The FDA has granted 510(k) clearance to LEADOPTIK’s Last Inch Assessment™ system, a first-of-its-kind biopsy-integrated depth imaging technology designed to improve real-time tissue confirmation during lung biopsies. By embedding high-resolution imaging directly into standard biopsy tools, the system aims to close a critical diagnostic gap and improve biopsy accuracy, reported to exceed 95% in preclinical data.

7. FDA Approves First Dual-Agent Eye Drop for Near Vision Loss

The FDA has approved Tenpoint Therapeutics’ YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) as the first fixed-dose, dual-agent topical therapy for presbyopia in adults, offering a non-invasive option to improve near vision. Approval was supported by phase 3 BRIO I and II trials demonstrating ≥3-line improvement in binocular uncorrected near visual acuity for up to 8 hours without significant loss of distance vision, with a favorable safety profile including low rates of ocular hyperemia.

The Future of Yuvezzi Eye Drops in Presbyopia, With John Hovanesian

Articles

January 2026 FDA actions spanned hematology, bleeding management, endocrinology, neuropsychiatry, harm reduction, pulmonary diagnostics, and ophthalmology. Caplacizumab-yhdp gained the first pediatric (≥12 years) indication for aTTP with high remission in retrospective data. A new 2‑g Fibryga kit enhanced dosing flexibility for acquired fibrinogen deficiency in critical bleeding. After large meta-analyses and real-world evidence, suicidal ideation language was removed from select GLP-1 RA labels. Novel clearances included at-home neuromodulation for MDD, discreet OTC naloxone packaging, biopsy-integrated lung imaging, and a dual-agent presbyopia eye drop.

This FDA News Month in Review provides a round-up of regulatory decisions from January 2026.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

FDA News

7 FDA Headlines You Missed in January 2026

Christian T. Ruff, MD, MPH is the Director of General Cardiology in the Cardiovascular Division at Brigham and Women's Hospital.

Abelacimab Reduces Bleeding in AF Consistently Across Age Groups

Abelacimab, an investigative monoclonal antibody FXI inhibitor, consistently reduced bleeding compared with rivaroxaban in patients with 

 regardless of age, according to a prespecified analysis of the AZALEA-TIMI 71 trial.

Currently available anticoagulants, such as direct oral anticoagulants (DOACs) or warfarin, are associated with a higher bleeding risk in older patients. In the AZALEA-TIMI 71 trial, investigators compared the safety of abelacimab and rivaroxaban, investigating the former’s potential as an FXI inhibitor for reducing bleeding rates.

“What was really remarkable was that when you look at both abelacimab doses, you have this low level of bleeding, and it essentially stays there even in patients who are 80, 90 years of age,” Christian Ruff, MD, MPH, director of general cardiology in the cardiovascular division at Brigham and Women’s Hospital, told 

 in an exclusive interview. “That’s really important because we’re starting to worry more about lifelong anticoagulation in the elderly. This shows that, as patients age, they’re really not accruing additional risk of bleeding with abelacimab.”

AZALEA-TIMI 71 was a multicenter, randomized, active-controlled phase 2b study conducted at 92 locations worldwide. Investigators enrolled patients ≥55 years old with a history of AF or atrial flutter and planned indefinite coagulation. Additionally, patients with a CHA2DS2-VASc of ≥4 or a CHA2DS2-VASc of ≥3 with either creatinine clearance ≤50 mL/min or planned concomitant use of antiplatelet medication for the duration of the trial were eligible for enrollment.

Patients were excluded if they had intracranial or intraocular bleeds within the 3 months prior to screening or clinically significant mitral stenosis, defined as a valve area <1.5 cm2. Additionally, those with mechanical heart valves or other indications for anticoagulation therapy besides AF, those with known presence of an atrial myxoma or left ventricular thrombus, and those with a history of left atrial appendage closure or removal, among other criteria, were excluded.

A total of 1287 patients were enrolled in the trial and were randomly assigned in a 1:1:1 ratio to either blinded subcutaneous adelacimab 150 mg or 90 mg once monthly, or open-label oral rivaroxaban at 20 mg once daily. The rivaroxaban dose was lowered to 15 mg if creatinine clearance was ≤50 mL/min. The study ran from March 2021 to September 2023, with the present data analysis performed from February to May 2025.

Investigators found that the incidence of major or CRNM bleeding in the rivaroxaban arm was 10.3 per 100 patient-years in those ≥75 years versus 6.7 per 100 patient-years in those <75 years. By contrast, the incidences were 3.2 and 4.1 per 100 patient-years in those ≥75 years and 2 and 2.5 per 100 patient-years among those <75 years in the 90 and 150 mg abelacimab arms, respectively.

Both doses of abelacimab substantially reduced major or CRNM bleeding versus rivaroxaban, with consistent relative reductions among patients ≥75 years (HR, 0.32; 95% CI, 0.17-0.6; and HR, 0.4; 95% CI, 0.22-0.73; for abelacimab 90 mg and 150 mg vs rivaroxaban, respectively) compared to those <75 years (HR, 0.28; 95% CI, 0.12-0.61; and HR, 0.35; 95% CI, 0.17-0.7; 

 = 0.85 and 0.84, respectively). These results were consistent irrespective of the threshold for age stratification, such as ≥80 vs <80 years or ≥85 vs <85 years.

Notably, continuous age analysis showed that major/CRNM bleeding probability gradually increased with advancing age in the rivaroxaban arm but remained stable across all age groups in both abelacimab arms.

“One of the big challenges that we face in clinical practice is that somewhere between 30 to 50% of patients who have atrial fibrillation either are not started on an anticoagulant or discontinue one. And the primary reason for that is that they have bled before, or they have a fear of bleeding,” Ruff said. “What will make that conversation even easier, though, is if we could say we have a drug that’s associated with 60, 70, 80% less bleeding than anything you’ve used before.”

Al Said S, Patel SM, Giugliano RP, et al. Abelacimab vs rivaroxaban in older individuals with atrial fibrillation. JAMA Cardiology. Published online February 4, 2026. 

Anthos Therapeutics, Inc. Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71). ClinicalTrials.gov Identifier: NCT04755283. Updated November 6, 2025. Accessed February 6, 2026. 

https://clinicaltrials.gov/study/NCT04755283

Videos

Ruff explains his prespecified analysis of the phase 2b AZALEA-TIMI 71 trial, highlighting abelacimab’s efficacy and durability compared to rivaroxaban.

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

Abelacimab Reduces Bleeding in AF Consistently Across Age Groups, With Christian Ruff, MD

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.

 who have inadequate responses to dupilumab and switch to upadacitinib may experience significant improvements in lesions and skin outcomes, according to recent data.

Upadacitinib, a selective Janus kinase (JAK) 1 inhibitor approved by the US Food and Drug Administration for moderate-to-severe atopic dermatitis in adults and adolescents, has previously been evaluated in head-to-head Level Up and Heads Up clinical trials.

, investigators assessed switching to upadacitinib among those with an inadequate response in the head and neck region after dupilumab use.

In this post hoc analysis, the investigative team looked at pooled data from a pair of direct comparison trials assessing upadacitinib versus dupilumab: the LEVEL UP study (NCT05601882) and the HEADS UP study (NCT03738397). those involved in LEVEL UP were initially randomized to be treated either with dupilumab 300 mg or upadacitinib 15 mg. Prior to the beginning of the open-label extension (OLE) at the 16-week mark, subjects on upadacitinib could have their dose raised to 30 mg based on their clinical response.

At week 16 of LEVEL UP, individuals without attainment of adequate disease control, defined as less than 75% improvement in Eczema Area and Severity Index (EASI75), followed different pathways of treatment. Those already given upadacitinib either stayed on their current dose or escalated to a 30 mg dose, while subjects originally assigned to dupilumab switched to upadacitinib 15 mg. They had the option to escalate to upadacitinib 30 mg at the 20-week mark, depending on response to their medication.

In the HEADS UP trial, those evaluated were randomized at the point of baseline to either dupilumab 300 mg or upadacitinib 30 mg, and the OLE phase took place at the 24-week mark. Individuals who completed the double-blind period and chose to continue entered the OLE and were given upadacitinib 30 mg. For those who were dupilumab-treated who also had an inadequate response in the head and neck (HN) region, defined as failure to attain HN EASI75, outcomes were assessed at the 4 and 16-week marks after changing to upadacitinib therapy.

These evaluations were aimed at the proportion of participants reaching HN EASI75, EASI90, and EASI100. Outcomes related to itch, across both studies, were evaluated via the Worst Pruritus Numerical Rating Scale (WP-NRS). The investigators’ analyses included the proportion of subjects who reported a clinically meaningful improvement, defined as at least a 4-point reduction, as well as those achieving minimal or no itch, indicated by WP-NRS scores of 0 or 1. All outcomes related to treatment efficacy were determined through the use of the observed case analyses.

The researchers observed similar baseline demographic and disease characteristics between patients involved in the LEVEL UP and HEADS UP trials. In LEVEL UP, the majority of those evaluated shifting from dupilumab to upadacitinib were successful in attaining HN EASI75, with a substantial proportion also achieving HN EASI90 and EASI100.

Among those who switched, the investigators observed, adjusted median HN EASI scores improved by 87.9% from the point of baseline by 16 weeks after the shifts in treatment. Additionally, the team highlighted comparable results in HEADS UP, where most of those evaluated who switched from dupilumab to upadacitinib attained HN EASI75 and EASI90. Many also reached complete clearance, reflected by EASI100 scores.

In this cohort, adjusted median HN EASI scores were shown to have improved by 97.5% from baseline at 16 weeks post-therapy switch. Across both studies, most of those evaluated experienced clinically meaningful itch severity reductions. Also, a notable proportion reported minimal or no itch within a single month of beginning upadacitinib therapy following the switch from dupilumab.

DaSilva D, Shahriari M, Bunick C, et al. Head and Neck Atopic Dermatitis: Therapeutic Response After Switching to Upadacitinib in Moderate-to-Severe Atopic Dermatitis Patients Who Had Inadequate Response to Dupilumab. Presented at: Maui Derm Hawaii 2026; January 25-29, 2026; Maui, Hawaii.

Bunick CG, Irvine AD, Levy GF, et al. Safety of upadacitinib in atopic dermatitis in randomized clinical trials across 6 years. J Eur Acad Dermatol Venereol. 2025 Nov 15. 

Switching moderate-to-severe atopic dermatitis patients with inadequate head/neck response on dupilumab to upadacitinib was associated with rapid and substantial improvements in regional disease activity and pruritus. Post hoc pooled analyses from LEVEL UP and HEADS UP evaluated head/neck EASI responses and WP-NRS outcomes after transition to upadacitinib, with dose escalation permitted in predefined windows. Most switchers achieved HN EASI75 and many reached deeper responses (EASI90/100). Adjusted median HN EASI improved ~88% and ~98% by 16 weeks, with clinically meaningful itch reductions often within 4 weeks.

Investigators assessed the efficacy of switching to upadacitinib in those with atopic dermatitis who had an inadequate response to dupilumab.

Atopic Dermatitis

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

Dermatology

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

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Upadacitinib Switch from Dupilumab Effective in Head and Neck Atopic Dermatitis 

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.

Credit: Comprehensive Allergy Centre Charité

An updated international guideline for , finalized at a global consensus conference in December 2024, reinforces a streamlined diagnostic approach while incorporating new evidence on emerging therapies, biomarkers, and disease mechanisms in chronic urticaria.

Developed using Cochrane and GRADE methodology, the revision reflects the work of >200 experts from 59 countries and represents the first major update since 2022.

 For clinicians, the update clarifies where evidence has matured meaningfully, particularly regarding the use of biomarkers, the role of provocation testing in chronic inducible urticaria, treating pediatric patients, and evaluating next-generation therapies for refractory disease.

The guideline continues to define urticaria as “a condition characterized by the development of wheals (hives), angioedema, or both.”

Wheals are characterized by 3 features: a clearly defined, superficial swelling that varies in size and shape and is usually surrounded by redness; itching or sometimes a burning sensation; and a short duration, with the skin returning to normal within 30 minutes to 24 hours. Angioedema is defined by a sudden, marked deep swelling of the lower dermis, subcutaneous tissue, or mucous membranes that is skin colored or erythematous; sensations of tingling, burning, tightness, and sometimes pain rather than itching; and a slower resolution than wheals, with symptoms that may last up to 72 hours.

Therapeutic goals emphasized in the guideline include, when possible, complete symptom control, avoidance of known eliciting factors, induction of tolerance in select chronic inducible urticaria subtypes, and pharmacologic prevention of mast cell mediator release.

Experts conducted a systematic review of randomized controlled trials across 3 databases through February 9, 2024. Of 1946 records identified, 12 trials met inclusion criteria. The update incorporates 12 new or revised GRADE evidence profiles and evidence-to-decision frameworks.

Although disease duration, activity, and treatment response, as well as laboratory markers, are commonly assessed in chronic spontaneous urticaria (CSU), the guideline states that no biomarker has sufficient predictive accuracy for routine clinical use. The document also highlights growing recognition that some urticaria therapies may beneficially affect comorbid conditions, including omalizumab and dupilumab in asthma, dupilumab in atopic dermatitis, and omalizumab in food allergy and chronic rhinosinusitis with nasal polyps.

Stronger consensus on provocation testing

The guidelines recommend provocation testing to diagnose chronic inducible urticaria. It also recommends the use of provocation thresholds and validated patient-reported outcome tools to assess disease activity and control.

New recommendations support the use of the same treatment algorithm in children as adults, with caution regarding age, weight, and regulatory approvals. Recent evidence suggests disease characteristics and treatment responses in pediatric patients largely mirror those seen in adults. To date, only UAS7 and UCT have been validated in children.

The following questions and responses are drawn directly from the international urticaria guideline recommendations, verbatim.

The guideline recommends classifying urticaria by duration as acute (≤ 6 weeks) or chronic (> 6 weeks), and by etiology as spontaneous (no identifiable trigger) or inducible (a specific, reproducible trigger).

Should the current classification of chronic urticaria be maintained?

Yes. The guideline recommends maintaining the existing classification system.

Should routine diagnostic testing be performed in acute urticaria?

The guideline recommends against routine diagnostic testing in acute spontaneous urticaria.

What diagnostic measures are recommended in chronic spontaneous urticaria?

Limited investigations are recommended. Basic testing includes a differential blood count and CRP and/or ESR. In specialized care settings, total IgE and IgG anti–thyroid peroxidase antibodies may be considered, with further testing guided by clinical history and disease severity.

How should chronic inducible urticaria be evaluated?

Provocation testing is recommended for diagnosis. Provocation threshold measurements and the Urticaria Control Test (UCT) are recommended to assess disease activity and control.

Which tools should be used to monitor disease activity and control?

For disease activity, the guideline recommends UAS7 and/or the Angioedema Activity Score (AAS). For disease control, UCT and/or the Angioedema Control Test (AECT) are recommended.

What is the recommended first-line treatment?

Second-generation H1-antihistamines are recommended as first-line therapy for all forms of urticaria.

For patients with chronic urticaria unresponsive to standard dosing, updosing second-generation H1-antihistamines up to fourfold is recommended before advancing to other therapies. Doses above fourfold are not recommended.

What add-on therapies are recommended for antihistamine-refractory disease?

Omalizumab is recommended as add-on therapy for patients unresponsive to high-dose antihistamines. Dupilumab and remibrutinib may be considered as add-on options, although use may be off-label. Ciclosporin is suggested when licensed options are ineffective or unavailable.

The guideline strongly recommends against long-term systemic corticosteroid use. A short rescue course may be considered for acute exacerbations.

Should the same treatment algorithm be used in children, pregnancy, and lactation?

The guideline suggests using the same algorithm with caution in children and in pregnant or lactating women, following individualized risk–benefit assessment and avoiding contraindicated therapies.

Zuberbier T, Hameed Ansari Z, Abdul Latiff AH, et al. The International Guideline for the Definition, Classification, Diagnosis and Management of Urticaria. 

Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. 

The 2024 global update for urticaria preserves the stepwise algorithm and clarifies evidence on biomarkers, provocation testing, pediatric care, and emerging therapies.

Urticaria

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

Updated Urticaria Guidelines Clarify Diagnosis, Biomarkers, Treatment Pathways

David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine.

On February 2, 2026, Aquestive Therapuetics announced that the 

 had issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for dibutepinephrine (Anaphylm), an orally dissolving epinephrine sublingual film, to treat 

Despite dibutepinephrine having strong data across > 10 studies with nearly 1,000 administrations across adult and pediatric populations, the FDA cited usability concerns. The agency noted difficulty opening the pouch and incorrect film placement.

To address these concerns, Aquestive plans on modifying the packaging, instructions for use, and labeling, as well as conducting a new human factors validation study and a pharmacokinetics study. The company anticipates resubmission in the third quarter of 2026.

Although it may be awhile before epinephrine sublingual film becomes available to the public as another fast-acting, needle-free option, HCPLive spoke with trial investigator David Golden, MD, an associate professor from Johns Hopkins, 

on what this treatment could mean for anaphylaxis management

 In this Q&A, Golden shared how epinephrine sublingual film (Anaphym) differs from autoinjectors, its rapid symptom reduction, and the role it plays in improving real-world readiness for anaphylaxis.

How does sublingual epinephrine delivery compare with autoinjectors in terms of onset, absorption, and usability?

 We like the fact that Anaphylm works very rapidly, as fast as the auto injector. As far as how it builds up to its peak level in the system, it's very comparable to auto-injectors.

Many doctors in a hospital and clinic… [still] give epinephrine… [with] a syringe and needle. They don't use an auto-injector. That's actually not nearly as fast as Anaphylm or auto injectors.

[Epinephrine sublingual film is] not only easy to carry but easy use because it’s so small. It’s something you can just pop under your tongue in a moment. This is not something that needs training. Usability is a very high level…even in an emergency… which is one of the problems with some existing products. In… panic or emergency…everything gets harder to use. This is quite easy to use.

Absorption is part of what allows it to build up quickly. The problem with every type of epinephrine is getting it into the system…one of the problems with epinephrine is that…it constricts blood vessels. Now, that's great for helping your blood pressure go up when you have anaphylaxis, but it means that wherever you put it, it fights its own absorption.

Whether you inject it in the muscle, it actually is a little bit of a problem there. If you just sprayed epinephrine in your nose or in your mouth, would it get absorbed? Hardly at all, because it would block itself off. So, each of these products has to have something in it that helps absorption.

Anaphylm is a really engineered platform for delivering epinephrine into the system, dissolving under the tongue and releasing it into the system. One of the key features is that the end of [the] film is a pro-drug. It's a form of epinephrine that doesn't cause that local problem with absorption. It can easily be absorbed, and after it gets into the system, [that] is when it gets broken down into epinephrine.

How should clinicians interpret the rapid symptom resolution observed in the pivotal studies?

 The mean time to complete resolution of symptoms was 15 minutes after giving the Anaphylm under the tongue.

[In the trial], the idea [was] to let the reaction build up until [participants] can't stand it anymore…and then they [could] take the food out and take the Anaphylm. [This is] mainly to see how it's absorbed, but also to see what happens to the symptoms. When they did that, the symptoms completely went away after 15 minutes, initially in the study, before there was an initial oral food challenge…to confirm that we had the right patients, that they were going to get this kind of reaction in the mouth.

They're not dangerous reactions. Usually, when [people] get those reactions, [they] don't necessarily take medication, but when they didn't take medication in that initial phase of the study, the mean time to resolution [was] 74 minutes.

What should clinicians understand about the strength of the evidence supporting this product as they digest the FDA’s decision?

 We have to keep in mind that there have been… at least 10 or 11 clinical studies with probably close to 1000 administrations in hundreds of subjects, including single dose and repeated dose. That's a lot of experience with the Anaphylm product for the company to be able to provide information to clinicians as to how it performs, how it gets into the system, what kind of effects it has, the desirable effects, which are really good…as far as it being able to counteract anaphylaxis and the pretty good side effect profile.

What role do you see epinephrine sublingual film playing in improving real-world readiness and response to anaphylaxis?

 Anaphylm will really be a big step in improving [the] readiness of people to deal with anaphylaxis, for themselves, as caregivers, and even as innocent bystanders. It's just so easy to carry, use, and be available.

Right now, we're so concerned…that most people don't use epinephrine when they should. Just delaying or not using epinephrine… leads to more problems with more severe reactions in hospitalizations and intensive care. I think, in the real world, we're going to see more people using epinephrine before deciding even whether they need to go to the emergency department.

What remaining questions about non-injectable epinephrine do you think future studies will need to address?

 Future studies absolutely need to address the confidence that everyone wants to have in an epinephrine product. The prescribers, the patients, and caregivers want to know that this has been tried and tested and worked as good as you expect epinephrine to work. You expect it to work fast and get rid of your reaction. So, do we know that? Not really.

We haven't seen published evidence that [sublingual epinephrine film] … works in all kinds of anaphylactic reactions. We need to see that, but these studies are very hard to do. It's hard to be there when someone goes into anaphylaxis in a restaurant…but there are ways to do this, and we're looking forward to getting more of that.

Right now, we can say that we expect it to work, and the evidence…is based on the way that…it does get into the system. We know that in the system, these [epinephrine] products do give the results you expect…like the blood pressure goes up. So, if it does that the same way that an auto injector does, of course, it's going to work. That's the reason that [Neffy was] approved…But until there are actually 1000 reactions that have been treated, we can't say that there have been 1000 reactions treated, and it worked 80 or 90 or 100% of the time.

Brooks A. FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions. HCPLive. February 2, 2026. 

https://www.hcplive.com/view/fda-issues-crl-to-dibutepinephrine-anaphylm-sublingual-film-for-type-1-allergic-reactions

Aquestive Therapeutics. Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™. February 2, 2026. Accessed February 2, 2026. 

https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-issuance-complete-response

Golden G. Anaphylm Remains Promising for Anaphylaxis Despite FDA CRL, With David Golden, MD. HCPLive. Published on February 3, 2026. Accessed on February 6, 2026. 

https://www.hcplive.com/view/anaphylm-remains-promising-anaphylaxis-despite-fda-crl-david-golden-md

Aquestive Therapeutics received an FDA Complete Response Letter for dibutepinephrine (Anaphylm), an orally dissolving sublingual epinephrine film intended for Type 1 allergic reactions, citing human factors issues rather than pharmacology. The agency flagged difficulty opening the pouch and incorrect film placement, despite a sizable clinical package. Planned remediation includes packaging and labeling revisions, updated instructions for use, a new human factors validation study, and an additional pharmacokinetics study, with resubmission targeted for Q3 2026.

Despite an FDA CRL over usability, trial data suggest the needle-free epinephrine film rivals autoinjectors in speed and absorption, with promise for real-world readiness.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

Potential of Epinephrine Sublingual Film for Anaphylaxis, With David Golden, MD

John Hovanesian, MD, is the principal and owner of Harvard Eye Associates.

Hovanesian breaks down the process by which Yuvezzi received FDA approval and discusses the prescription and application of the new drug.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

The Future of Yuvezzi Eye Drops in Presbyopia, With John Hovanesian, MD

Luis Sanchez Russo, MD, is a nephrologist affiliating with Advent Health.

The 2025 KDIGO guidelines guide mechanism-driven therapy in IgA nephropathy, highlighting targeted interventions across the 4-hit disease cascade.

Nephrology

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

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

KDIGO 2025 Guides Mechanism-Driven Therapy in IgA Nephropathy, With Luis Russo, MD, MS

Dr Cristancho describes how patient goals, time horizon, and clinical drivers of obesity guide the selection and counseling of non-incretin weight loss medications.

Aligning non-incretin pharmacotherapy with patient goals and mechanisms of disease

In this segment, Cagney Cristancho, MD, outlines why non-incretin pharmacologic options remain essential in obesity care despite the rapid expansion of incretin-based therapies.

Non-incretin harmacotherapy in an incretin-dominated obesity landscape

Catch up on dermatology news from January 2026, expert insights on dermatologic disease management, and more.

6 Dermatology Headlines You Missed in January 2026

Walter J. Liszewski, MD, is an associate professor of dermatology and cancer epidemiology at Northwestern University Feinberg School of Medicine.

This segment of Liszewski’s interview at Maui Derm Hawaii 2026 highlights additional takeaways for clinicians regarding the treatment of contact dermatitis.

Diagnostic Approaches to Contact Dermatitis Overlap with Atopic Disease, With Walter Liszewski, MD

New data presented at EHSF in Malta boasts a reduced proportion of patients with severe HS at 3 years.

Hidradenitis Suppurativa

Hidradenitis Suppurativa 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 dermatology research, treatment, and drug development.

Bimekizumab Demonstrates Long Term Efficacy in Hidradenitis Suppurativa

Eliezer Katz, MD, is the chief medical officer at Eledon Pharmaceuticals. 

Tegoprubart, a CD40L-targeted therapy, may improve long-term kidney transplant outcomes by reducing immune-mediated injury.

Targeting Costimulatory Pathways in Kidney Transplant With Eliezer Katz, MD

Eric White, MD, global clinical development lead for rheumatology and pulmonology at Boehringer Ingelheim Pharmaceuticals

The DROP-FPF Phase 3b trial will use automated HRCT biomarkers to assess whether early treatment with nerandomilast can slow disease progression before lung function declines.


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.

Pulmonary Fibrosis

AI CT Tool for Early Pulmonary Fibrosis Detection Enters Phase 3, With Eric White, MD

Andrew Russman, DO, is a neurologist and the section head of stroke and vascular neurology at the Cleveland Clinic.

Russman highlights asundexian’s efficacy in patients following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.

Stroke

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

Latest News

7 FDA Headlines You Missed in January 2026

Abelacimab Reduces Bleeding in AF Consistently Across Age Groups, With Christian Ruff, MD

Upadacitinib Switch from Dupilumab Effective in Head and Neck Atopic Dermatitis

Updated Urticaria Guidelines Clarify Diagnosis, Biomarkers, Treatment Pathways

Potential of Epinephrine Sublingual Film for Anaphylaxis, With David Golden, MD