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 (FDA) issuance of a Complete Response Letter (CRL) o Aquestive Therapeutics’ New Drug Application (NDA) for dibutepinephrine (Anaphylm) Sublingual Film for the treatment of Type I allergic reactions, new phase 2 topline data from Arcutis Biotherapeutics for roflumilast (Zoryve) cream 0.05% in infants with atopic dermatitis, an accepted Biologics License Application from Galderma for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal lines, regulatory submissions for upadacitinib (Rinvoq; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo, and topline results from the phase 2b VESPER-3 study of Pfizer’s PF’3944 (MET-097i) in adults with obesity or overweight without type 2 diabetes.

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 February 01, 2026—let’s jump in!

FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions

Announced on February 2, 2026, the FDA issued a CRL to Aquestive Therapeutics’ NDA for dibutepinephrine (Anaphylm) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing ≥ 30kg (approximately 66 pounds). The January 30, 2026, CRL detailed deficiencies in the dibutepinephrine human factors (HF) validation study, including instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis.

Positive Topline Data Released on Roflumilast Cream in Infants with Atopic Dermatitis

On February 2, 2026, Arcutis Biotherapeutics announced positive topline results from the INTEGUMENT-INFANT phase 2 study evaluating the safety, tolerability, and efficacy of roflumilast (Zoryve) cream 0.05% in infants aged 3 months to < 24 months with atopic dermatitis. In the study, the highly selective and potent topical PDE4 inhibitor was well tolerated with a safety profile consistent with previous clinical trials. Results showed roflumilast cream improved the severity of disease and reduced the area of skin affected by atopic dermatitis, with 58% of participants achieving EASI-75 at week 4.

FDA Accepts Resubmitted BLA for RelabotulinumtoxinA for Glabellar and Lateral Canthal Lines

On February 2, 2026, Galderma announced the FDA’s acceptance of the Company’s BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. The acceptance follows collaboration between Galderma and the Agency to implement adjustments to the Company’s manufacturing process.

Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with Vitiligo

On February 3, 2026, AbbVie announced the submission of applications to the FDA and EMA for a new indication for upadacitinib (Rinvoq; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV). The regulatory submissions are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV.

VESPER-3: Positive Results of Long-Term GLP-1 PF’3944 in Overweight and Obesity Without T2D

On February 3, 2026, Pfizer announced positive topline results from the phase 2b VESPER-3 study investigating monthly maintenance dosing of its fully-biased, ultra-long-acting, injectable GLP-1 receptor agonist PF’3944 (MET-097i) in adults with obesity or overweight without type 2 diabetes. The study met the primary endpoint of statistically significant weight reduction at 28 weeks with a competitive tolerability profile. Of note, weight loss continued after the pre-planned switch from weekly to monthly dosing, with no plateau observed at 28 weeks.

Articles

Regulatory and clinical milestones spanned allergy, dermatology, aesthetics, immunology, and metabolic disease. A sublingual epinephrine alternative for anaphylaxis received an FDA complete response letter centered on human factors failures that could compromise emergency use. A topical PDE4 inhibitor demonstrated favorable safety and rapid efficacy in infantile atopic dermatitis, including high week-4 EASI-75 rates. In aesthetics, a botulinum toxin BLA was accepted after manufacturing-process modifications. Upadacitinib advanced toward a vitiligo indication via FDA/EMA submissions. An ultra-long-acting GLP-1RA showed sustained weight loss through weekly-to-monthly dosing transition.

Stay updated with the latest healthcare breakthroughs, including topline phase 2 data, FDA actions, and regulatory submissions, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 02/01

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 new phase 2 data on CT-388 for obesity, the US Food and Drug Administration (FDA) approval of a labeling supplement permitting repeat administration of travoprost intracameral implant (iDose TR) in open-angle glaucoma or ocular hypertension, new American Society of Hematology (ASH) guidelines on light chain (AL) amyloidosis, the FDA approval of carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% (Yuvezzi) for presbyopia, and the US Centers for Medicare & Medicaid Services selection of 15 high-cost drugs for the third cycle of the Medicare Drug Price Negotiation Program, including the first-ever Part B drugs.

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 January 25, 2026—let’s jump in!

Genentech Reports Positive Results from Phase 2 Trial of CT-388 in Obesity

On January 27, 2026, Genentech, a member of the Roche Group, announced positive topline results from CT388-103, a phase 2 clinical trial of CT-388, an investigational dual GLP-1/GIP receptor agonist being developed for the treatment of obesity.

Results showed once-weekly subcutaneous injections of CT-388 titrated up to 24 mg resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks. A clear dose-response relationship on the weight loss was also observed.

FDA Approves Labeling Update for iDose TR for Open-Angle Glaucoma and Ocular Hypertension

On January 28, 2026, the FDA approved a labeling supplement permitting repeat administration of travoprost intracameral implant (iDose TR) for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The update modifies prior labeling that limited use to a single administration and is based on accumulated clinical safety data, including corneal endothelial outcomes, submitted by the manufacturer.

ASH Releases New Clinical Practice Guidelines for Diagnosing AL Amyloidosis

On January 28, 2026, ASH published new clinical practice guidelines aimed at improving the early, timely, and accurate diagnosis of AL amyloidosis. The document, published in 

, outlines best practices to support clinicians in recognizing and diagnosing AL amyloidosis, a disease frequently missed or diagnosed late due to its heterogeneous presentation.

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

On January 28, 2026, the FDA approved Tenpoint Therapeutics’ carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% (Yuvezzi) for the treatment of presbyopia in adults, representing the first regulatory authorization of a fixed-dose, dual-agent topical therapy for age-related near vision degradation.

CMS Selects 15 Drugs for Third Cycle of Medicare Drug Price Negotiation Program

On January 27, 2026, the US Centers for Medicare & Medicaid Services (CMS) announced the selection of 15 high-cost prescription drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B for the third cycle of the Medicare Drug Price Negotiation Program. CMS additionally selected 1 previously negotiated drug, linagliptin (Tradjenta), for the program’s first renegotiations. Negotiations with participating drug companies will occur in 2026 and any negotiated and renegotiated prices will become effective January 1, 2028.

Genentech's phase 2 trial of CT-388 for obesity demonstrated significant weight loss without plateauing at 48 weeks. The FDA approved a labeling update for iDose TR, allowing repeat administration for open-angle glaucoma and ocular hypertension. ASH released new guidelines for diagnosing AL amyloidosis to improve early detection. The FDA approved Yuvezzi, the first dual-agent eye drop for presbyopia. CMS selected 15 high-cost drugs for the third cycle of the Medicare Drug Price Negotiation Program, including Part B drugs, with negotiations set for 2026 and prices effective in 2028.

Stay updated with the latest healthcare breakthroughs, including new phase 2 obesity data, FDA actions, and new hematology guidelines in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 01/25

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 new phase 2 data on NS002 for the treatment of 

, the publication of the 2026 Heart Disease and Stroke Statistics from the American Heart Association (AHA), new clinical guidance from the American College of Chest Physicians (CHEST) on biologic management in severe 

, findings from a national survey on topical steroid use in dermatology, and data from 2 phase 3 studies of amlitelimab for the treatment of patients ≥ 12 years of age with moderate-to-severe 

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 January 18, 2026—let’s jump in!

Phase 2 Data Show NS002 Intranasal Epinephrine Acts Faster Than EpiPen

On January 20, 2026, Nasus Pharma announced positive interim results from its phase 2 clinical study of NS002, the Company's investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. Results showed NS002 achieved faster absorption, higher peak concentrations, and greater early epinephrine exposure compared to intramuscular EpiPen® autoinjector.

AHA 2026 Heart Disease and Stroke Statistics: Progress and Pitfalls, With Latha Palaniappan, MD, MS

The 2026 Heart Disease and Stroke Statistics from the AHA spotlight heart disease and stroke as being among the leading causes of death in the US, with heart disease remaining the leading cause of death and stroke moving up to the #4 spot.

New CHEST Recommendations Guide Biologic Use for Severe Asthma

CHEST released a new clinical guideline on biologic management in severe asthma, offering 7 evidence-based recommendations to provide a framework for pulmonologists, allergists, and immunologists to implement in their own practice. The document examines existing biologics and provides evidence-based recommendations for which biologics to consider for different patient populations.

Topical Steroid Concerns in Dermatology Highlighted in Nationwide Survey

ON January 21, 2026, Arcutis Biotherapeutics announced results of 

Skin Insights: Steroid Perceptions in Chronic Inflammatory Skin Diseases

, a nationwide survey of adults and parents of children with plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. Results showed nearly 9 in 10 adults and parents of children with plaque psoriasis, atopic dermatitis, and seborrheic dermatitis being treated with topical steroids are concerned about side effects, and nearly 8 in 10 adults and parents agreed that their or their child's treatment plan focuses on reactively “taming a flare” rather than proactive long-term solutions. Additionally, when their skin condition is uncontrolled, nearly all adults and children experience emotional, mental, and daily life challenges

Amlitelimab Effective, Safe for Atopic Dermatitis in Patients 12 Years and Older

On January 23, 2026, Sanofi announced results from 2 global phase 3 studies – SHORE and COAST 2 – of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand, for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis. In these two phase 3 studies amlitelimab was well-tolerated and the safety profile was consistent with previously reported data.

Nasus Pharma's phase 2 study of NS002 shows faster absorption and higher peak concentrations than EpiPen for anaphylaxis treatment. The AHA's 2026 statistics highlight heart disease as the leading cause of death, with stroke now fourth. CHEST's new guidelines provide evidence-based recommendations for biologic management in severe asthma. A nationwide survey reveals significant concerns about topical steroid side effects in dermatology. Sanofi's phase 3 studies demonstrate amlitelimab's efficacy and safety for treating moderate-to-severe atopic dermatitis in patients aged 12 and older.

Stay updated with the latest healthcare breakthroughs, including new phase 2/3 data and updated asthma guidelines, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 01/18

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) clearance of Medtronic’s MiniMed Go Smart Multiple Daily Injection app for use by pediatric and adult patients with type 1 diabetes or type 2 diabetes, the approvals of Neurolief’s ProlivRx brain neuromodulation therapy for adults with major depressive disorder (MDD) who did not respond to ≥ 1 antidepressant and Emergent BioSolutions’ supplemental New Drug Application (sNDA) for over-the-counter naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability, extension of the review timeline for Travere Therapeutics’ sNDA for sparsentan (Filspari) for focal segmental glomerulosclerosis (FSGS), and request to remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that include such language.

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 January 11, 2026—let’s jump in!

FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

On January 12, 2026, the FDA granted 510(k) clearance to Medtronic’s MiniMed Go Smart Multiple Daily Injection (MDI) app for use by patients with type 1 diabetes or type 2 diabetes aged ≥7 years, as well as for children between 2-6 years under adult supervision.

The MiniMed Go Smart MDI system integrates the InPen smart insulin pen with the Instinct sensor developed by Abbott, all of which are connected through the MiniMed Go app. The system provides users with missed dose alerts to minimize glucose highs, action-oriented guidance in the event of a missed or miscalculated dose, and a dose calculator to simplify dose decision-making.

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

On January 12, 2026, the FDA approved Neurolief’s ProlivRx, the first at-home, physician-directed brain neuromodulation therapy for adults with MDD who did not respond to ≥ 1 antidepressant. The therapy can be delivered at home under physician supervision, eliminating the access and operational challenges of clinic-based treatments.

The approval was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating ProlivRx in MDD with inadequate response to antidepressant medications.

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

On January 13, 2026, the FDA requested the removal of information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that included such language. Affected products include liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

On January 13, 2026, Travere Therapeutics announced the FDA extension of the review timeline for the Company’s sNDA of sparsentan (Filspari) for FSGS. The Agency moved the Prescription Drug User Fee Act (PDUFA) target action date, which was expected on January 13, 2026, to April 13, 2026. No additional information relating to the safety or manufacturing of the drug was requested.

FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

On January 14, 2026, the FDA approved Emergent BioSolutions’ sNDA for over-the-counter (OTC) naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability.

The new case includes 2 blister packs, each enclosed with Quick Start Guide, and is designed to be compact, discreet and durable, with the goal of making naloxone more readily carried and available. The new design aims to reduce the stigma often associated with carrying naloxone and to increase its rates of carry and chances of its use in emergencies.

The FDA has recently cleared Medtronic's MiniMed Go Smart MDI app for pediatric and adult diabetes patients, enhancing insulin management. Neurolief's ProlivRx, an at-home neuromodulation device for major depressive disorder, received FDA approval, offering a new treatment avenue for patients unresponsive to antidepressants. The FDA also requested the removal of suicidal ideation warnings from GLP-1 RA therapies, citing no increased risk. Additionally, the FDA extended the review timeline for Travere Therapeutics' sparsentan for FSGS and approved new Narcan packaging to improve accessibility and usability.

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